The Recall Desk

Manufacturer

Codman & Shurtleff, Inc.

59 recalls in our database name Codman & Shurtleff, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
59
Critical
4
Severe
19
Most recent
2019-08-21

Of the 59 recalls from Codman & Shurtleff, Inc. we have scored against our rubric, 4 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (32%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 59

  • ModerateFDA (Devices)·Z-2280-2019·2019-08-21

    Codman Galaxy G3 Mini Microcoil Delivery System Recalled for Labeling Error

    Codman & Shurtleff Inc is recalling 28 units of the Galaxy G3 Mini Microcoil Delivery System because the label displays the incorrect coil length.

    Product
    GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1684-2015·2015-06-03

    Codman 3000 Series Refill Set Recalled for Leaking Needles

    Codman & Shurtleff, Inc. is recalling 5,463 units of the CODMAN 3000 Series Refill Set because the needles may leak from the hub connection.

    Product
    CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calib
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0091-2015·2014-10-29

    Codman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage

    Codman & Shurtleff is recalling Lumbar Drainage Catheter Kits because tubing may leak or disconnect, risking improper drainage or air entry.

    Product
    Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the inser
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0089-2015·2014-10-29

    Codman EDS 3 Drainage System Recalled for Potential CSF Leakage

    Codman & Shurtleff is recalling EDS 3 Drainage Systems because tubing may leak or disconnect, risking improper fluid drainage or air introduction.

    Product
    Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2015·2014-10-29

    Codman EDS 3 Drainage System Recalled for Tubing Leak Risk

    Codman & Shurtleff is recalling 93,558 EDS 3 Drainage Systems because tubing may leak or disconnect, risking improper fluid drainage or air introduction.

    Product
    Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2189-2014·2014-08-20

    Codman Certas Valve Recall Clarifies Pressure Specification in Instructions for Use

    Codman & Shurtleff, Inc. is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management o
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2184-2014·2014-08-20

    Codman Certas Valve Recall Clarifies Pressure Specification in Instructions for Use

    Codman & Shurtleff is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2185-2014·2014-08-20

    Codman Certas Valve Recalled to Clarify Pressure Specifications in Instructions

    Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2188-2014·2014-08-20

    Codman Certas Valve Recalled for Pressure Specification Clarification

    Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the Instructions for Use.

    Product
    Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2186-2014·2014-08-20

    Codman Certas Valve Recall Clarifies Pressure Specification in Instructions

    Codman & Shurtleff is recalling 9,498 implantable valves to clarify the pressure specification for the virtual off setting in the Instructions for Use.

    Product
    Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydroceph
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2187-2014·2014-08-20

    Codman Certas Valve Recalled to Clarify Pressure Specifications in Instructions

    Codman & Shurtleff is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8803 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management o
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2191-2014·2014-08-20

    Codman Certas Valve Recalled for Pressure Specification Clarification

    Codman & Shurtleff is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid)
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2190-2014·2014-08-20

    Codman Certas Valve Recalled for Pressure Specification Clarification

    Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-1572-2014·2014-05-21

    Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue

    Codman & Shurtleff is recalling 34 MedStream Programmable Infusion Pumps because they may trigger a low battery alarm at the beginning of the implanted life.

    Product
    MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1571-2014·2014-05-21

    Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue

    Codman & Shurtleff is recalling 90 MedStream Programmable Infusion Pumps because a small number may trigger a low battery alarm at the beginning of the implanted life.

    Product
    MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1468-2014·2014-04-23

    Codman Certas Programmable Valves Recalled for Missing Verification Tools

    Codman & Shurtleff is recalling 9,445 units of Certas Programmable Valves to ensure customers have tools to verify valve settings and location on x-ray images.

    Product
    CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Cath
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0859-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 895 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0860-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 431 Codman Certas Programmable Valves because they may not operate properly. These implantable devices are used to manage hydrocephalus.

    Product
    Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0862-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 369 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrosp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 746 Codman Certas Programmable Valves because they may not operate properly. The devices are used to manage hydrocephalus.

    Product
    Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and dra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 1,481 Codman Certas Programmable Valves because they may not operate properly, potentially affecting hydrocephalus management.

    Product
    Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 409 units of Codman Certas Programmable Valves because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cereb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 1,460 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocepha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0788-2014·2014-01-29

    Codman TRUFILL n-BCA Liquid Embolic System Recalled for Incorrect Instructions

    Codman & Shurtleff, Inc. is recalling 3,860 units of the TRUFILL n-BCA Liquid Embolic System due to incorrect instructions for use.

    Product
    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriove
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0789-2014·2014-01-29

    Codman TRUFILL n-BCA Liquid Embolic System Recalled for Incorrect Instructions

    Codman & Shurtleff, Inc. is recalling 7,983 units of the TRUFILL n-BCA Liquid Embolic System due to incorrect instructions for use.

    Product
    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arterioveno
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Codman & Shurtleff

company

Source: Wikidata (Q1106449), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.