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.

451–475 of 639

  • HighFDA (Devices)·Z-2677-2020·2020-07-29

    Boston Scientific Recalls IceFORCE 2.1 CX Cryoablation Needles

    Boston Scientific is recalling 39 IceFORCE 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2676-2020·2020-07-29

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration

    Boston Scientific is recalling 48 IcePearl 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2681-2020·2020-07-29

    Boston Scientific Recalls Prostate Cryoablation Kits Due to Needle Surface Deterioration

    Boston Scientific is recalling 71 IceFORCE 2.1 Prostate Cryoablation Kits because needle surfaces deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2678-2020·2020-07-29

    Boston Scientific Recalls IceFORCE Prostate Kit Due to Needle Surface Deterioration

    Boston Scientific is recalling 79 IceFORCE 2.1 CX Prostate Kits because needle surfaces deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2679-2020·2020-07-29

    Boston Scientific Recalls IcePearl 2.1 CX Prostate Kit Due to Needle Deterioration

    Boston Scientific is recalling 193 IcePearl 2.1 CX Prostate Kits because needle surfaces deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2675-2020·2020-07-29

    Boston Scientific Recalls IceFORCE Cryoablation Needles Due to Surface Deterioration

    Boston Scientific is recalling 18,440 IceFORCE 2.1 CX 90 Needle Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2680-2020·2020-07-29

    Boston Scientific Recalls Prostate Cryoablation Kits Due to Needle Deterioration

    Boston Scientific is recalling 88 Prostate Cryoablation Kits because needle surfaces deteriorated during procedures due to unexpected electrolysis.

    Product
    Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2674-2020·2020-07-29

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration

    Boston Scientific is recalling IcePearl 2.0 CX 90 Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2682-2020·2020-07-29

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration

    Boston Scientific is recalling 205 IcePearl 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2683-2020·2020-07-29

    Boston Scientific Recalls IceForce 2.1 CX Cryoablation Needles

    Boston Scientific is recalling 656 IceForce 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2045-2020·2020-05-27

    Boston Scientific Recalls AMS 700 Reservoirs Due to Labeling Error

    Boston Scientific is recalling five AMS 700 100 mL Spherical Reservoirs with InhibiZone because they were incorrectly labeled as a different model.

    Product
    AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1804-2020·2020-05-06

    Boston Scientific Recalls iLab Polaris Systems Due to Data Archiving Bug

    Boston Scientific is recalling 150 iLab Polaris and Ultrasound systems in Europe because a software bug prevents specific data from being archived without notifying the user.

    Product
    iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1798-2020·2020-05-06

    Boston Scientific Recalls MoXy Laser Fiber for Breakage Risk

    Boston Scientific is recalling MoXy Laser Fibers to update instructions and reduce the likelihood of metal cap and fiber tip breakage.

    Product
    MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2020·2020-03-25

    Boston Scientific DYNAGEN EL ICD DR Recall for Unapproved Software

    Boston Scientific is recalling one DYNAGEN EL ICD DR device because a software update downloaded unapproved applications to four programmers.

    Product
    Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of lif
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1511-2020·2020-03-25

    Boston Scientific LATITUDE Programming System Software Update Recall

    Boston Scientific is recalling four LATITUDE Programming System devices that downloaded unapproved software applications.

    Product
    Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all commu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0717-2020·2019-12-25

    Boston Scientific Recalls AngioJet Ultra Consoles Missing Operator's Manuals

    Boston Scientific is recalling 169 AngioJet Ultra Consoles because they were shipped without the required Operator's Manual.

    Product
    AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H 105650-024Z 105650-025 105650-025H 105650-025R 105650-026R Product Usage - The AngioJet all
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0667-2020·2019-12-18

    Boston Scientific Recalls Habib EUS RFA Electrode Tips Due to Thermal Injury Risk

    Boston Scientific is recalling 139 Habib EUS RFA electrode tips because capacitive coupling may cause thermal injury to tissue outside the target area.

    Product
    Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0668-2020·2019-12-18

    Boston Scientific Recalls Habib EUS RFA Electrode Tips Due to Thermal Injury Risk

    Boston Scientific is recalling 179 Habib EUS RFA electrode tips because capacitive coupling may cause unintended thermal injury to tissue outside the treatment area.

    Product
    Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2020·2019-12-04

    Boston Scientific Recalls Rebel Monorail Coronary Stent Systems

    Boston Scientific is recalling 14,145 Rebel Monorail PtCr Coronary Stent Systems because they may be missing a hydrophilic coating step.

    Product
    Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0577-2020·2019-12-04

    Boston Scientific Recalls Emerge Monorail PTCA Catheters Due to Coating Defect

    Boston Scientific is recalling Emerge Monorail PTCA Dilatation Catheters because they may lack a required hydrophilic coating. The recall covers 14,145 devices distributed nationwide and in Canada.

    Product
    Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No. H7493919312200,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0560-2020·2019-12-04

    Boston Scientific Pancreatic Stent Recalled for Incorrect Shelf Life Labeling

    Boston Scientific is recalling 35 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 66 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0558-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 66 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0578-2020·2019-12-04

    Boston Scientific Recalls Guidezilla II Catheters Due to Missing Coating

    Boston Scientific is recalling Guidezilla II Guide Extension Catheters because they may lack a hydrophilic coating, potentially affecting device performance.

    Product
    Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.
    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.

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.