The Recall Desk

Manufacturer

Boston Scientific Corporation

639 recalls in our database name Boston Scientific Corporation as the manufacturing or recalling firm.

What the numbers show

Total
639
Critical
57
Severe
102
Most recent
2026-09-09

Of the 639 recalls from Boston Scientific Corporation we have scored against our rubric, 57 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 102 (16%) 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.

551–575 of 639

  • HighFDA (Devices)·Z-0374-2018·2018-01-24

    Boston Scientific Recalls Pacemakers Due to Sensor Signal Issues

    Boston Scientific is recalling PROPONENT DR Pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.

    Product
    PROPONENT DR Pacemaker
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0078-2018·2017-11-15

    Boston Scientific Recalls 12 Resonate EL ICD Devices for Firmware Error

    Boston Scientific is recalling 12 Resonate EL ICD DR devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    RESONATE EL ICD DR, Model D433, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0079-2018·2017-11-15

    Boston Scientific Recalls Four VIGILANT X4 CRT-D Devices for Firmware Error

    Boston Scientific is recalling four VIGILANT X4 CRT-D devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1)
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0080-2018·2017-11-15

    Boston Scientific Recalls Four Momentum X4 CRT-D Devices for Firmware Error

    Boston Scientific is recalling four Momentum X4 CRT-D devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    MOMENTUM X4 CRT-D, Model G138, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0077-2018·2017-11-15

    Boston Scientific Recalls Five Resonate EL ICD VR Devices for Firmware Error

    Boston Scientific is recalling five Resonate EL ICD VR devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    RESONATE EL ICD VR, Model D432, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0081-2018·2017-11-15

    Boston Scientific Recalls 11 Resonate X4 CRT-D Devices for Firmware Error

    Boston Scientific is recalling 11 Resonate X4 CRT-D devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    RESONATE X4 CRT-D, Model G447, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-3132-2017·2017-09-20

    Boston Scientific Recalls FFR Link Signal Processing Modules for Missing Test Records

    Boston Scientific is recalling three FFR Link Signal Processing Modules because the device history record was missing documentation for final electrical testing.

    Product
    FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they c
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-3038-2017·2017-08-23

    Boston Scientific Recalls Emblem MRI S-ICD Devices Due to Energy Delivery Risk

    Boston Scientific is recalling approximately 9,200 Emblem MRI S-ICD devices because memory corruption may cause the device to deliver an atypical amount of energy.

    Product
    EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic br
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3039-2017·2017-08-23

    Boston Scientific Recalls SQ-RX 1010 Pulse Generators Due to Memory Corruption

    Boston Scientific is recalling approximately 12,450 SQ-RX 1010 Pulse Generators because memory corruption may cause the device to deliver an atypical amount of energy.

    Product
    SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3037-2017·2017-08-23

    Boston Scientific Recalls Emblem S-ICD Devices Due to Energy Delivery Risk

    Boston Scientific is recalling approximately 16,750 Emblem S-ICD devices because they may deliver atypical energy levels due to internal memory corruption.

    Product
    EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradyc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3043-2017·2017-08-23

    Boston Scientific Recalls Encore 26 Inflation Devices Due to Cracked Trays

    Boston Scientific is recalling 305,779 Encore 26 Inflation Devices worldwide because of complaints regarding cracked trays.

    Product
    Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2673-2017·2017-07-12

    Boston Scientific Retrieval Balloon Catheter Recalled for Labeling Error

    Boston Scientific is recalling 39 units of the Extractor Pro RX-S Retrieval Balloon Catheter because the label incorrectly identifies the injection location.

    Product
    Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2645-2017·2017-07-12

    Boston Scientific Imager II Angiographic Catheter Recall for Missing Seal

    Boston Scientific is recalling Imager II Angiographic Catheters because some units are missing the bottom pouch seal. The defect is obvious to the user.

    Product
    Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2674-2017·2017-07-12

    Boston Scientific Retrieval Balloon Catheter Recalled for Incorrect Injection Labeling

    Boston Scientific is recalling 32 units of Extractor Pro RX-S Retrieval Balloon Catheters because the labels incorrectly identify the injection location relative to the balloon.

    Product
    Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1922-2017·2017-05-10

    Boston Scientific Recalls Mislabeled JETSTREAM Atherectomy Catheters

    Boston Scientific is voluntarily removing three lots of JETSTREAM atherectomy catheters because some units were mislabeled with incorrect sizes.

    Product
    The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located at the catheter tip, which are designed to provide independent infusion and aspi
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-1781-2017·2017-04-19

    Boston Scientific Recalls Imager II Angiographic Catheters Due to Packaging Mislabeling

    Boston Scientific is recalling Imager II Angiographic Catheters because some packages are mislabeled as Contra 2 curve catheters when they contain Contra curve catheters.

    Product
    Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1401-2017·2017-03-15

    Boston Scientific Recalls AngioJet Ultra 5000 A Console Foot Switches

    Boston Scientific is recalling AngioJet Ultra 5000 A Console foot switches because they may stick during use, causing the device to operate continuously and undesirably.

    Product
    AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump, regulates fluid inflow and outflow, provides the operator with Ultra System set-up prompts, to
    Category
    Medical Device
    Distribution
    2 states

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.

Boston Scientific

worldwide developer, manufacturer and marketer of medical devices

Country
United States
Founded
1979

Official website

Source: Wikidata (Q894585), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.