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.

401–425 of 639

  • HighFDA (Devices)·Z-0673-2021·2020-12-30

    Boston Scientific Recalls IceSphere Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 92 units of IceSphere 1.5 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceSphere" 1.5 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0672-2021·2020-12-30

    Boston Scientific Recalls IceSphere Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 729 IceSphere 1.5 S 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceSphere" 1.5 S 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0666-2021·2020-12-30

    Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 4,645 IceRod 1.5 PLUS 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" 1.5 PLUS 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0668-2021·2020-12-30

    Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 93 units of IceRod 1.5 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" 1.5 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2021·2020-12-30

    Boston Scientific Recalls IceSphere Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 2,429 IceSphere 1.5 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceSphere" 1.5 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0678-2021·2020-12-30

    Boston Scientific Recalls IceRod MRI Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 3,894 IceRod 1.5 MRI 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" 1.5 MRI 90¿ Cryoablation Needle¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2021·2020-12-30

    Boston Scientific Recalls Prostate Cryoablation Kits Due to Gas Leaks

    Boston Scientific is recalling 178 IceRod i-Thaw Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    Five IceRod" i-Thaw" Prostate Cryoablation Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2021·2020-12-30

    Boston Scientific Recalls IceFORCE Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 22,289 IceFORCE 2.1 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceFORCE" 2.1 CX 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0660-2021·2020-12-30

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 8,453 IcePearl 2.1 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IcePearl" 2.1 CX 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0658-2021·2020-12-30

    Boston Scientific Recalls IceFORCE Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 75 units of IceFORCE 2.1 CX Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceFORCE" 2.1 CX Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0663-2021·2020-12-30

    Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 18,731 IceRod 1.5 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" 1.5 CX 90¿ Cryoablation Needle¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2021·2020-12-30

    Boston Scientific Recalls Prostate Cryoablation Kits Due to Gas Leaks

    Boston Scientific is recalling 117 IcePearl 2.1 CX Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    Three IcePearl" 2.1 CX Prostate Cryoablation Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0691-2021·2020-12-30

    Boston Scientific Recalls Prostate Cryoablation Kits Due to Gas Leaks

    Boston Scientific is recalling 243 IceRod i-Thaw Prostate Cryoablation Kits nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" i-Thaw" Prostate Cryoablation Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0693-2021·2020-12-30

    Boston Scientific Recalls IceRod He-Thaw Prostate Cryoablation Kits

    Boston Scientific is recalling 115 IceRod He-Thaw Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" He-Thaw Prostate Cryoablation Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0664-2021·2020-12-30

    Boston Scientific Recalls IceSphere Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 6,363 IceSphere 1.5 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceSphere" 1.5 CX 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0659-2021·2020-12-30

    Boston Scientific Recalls IceFORCE Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 740 IceFORCE 2.1 CX L 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceFORCE" 2.1 CX L 90¿ Cryoablation Needle
    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.