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.

1–25 of 639

  • HighFDA (Devices)·Z-3081-2026·2026-09-09

    Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software

    Boston Scientific is recalling LUX-Dx Insertable Cardiac Monitor server software due to potential delays in Atrial Fibrillation Burden Alerts, which may delay clinical evaluation.

    Product
    LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3083-2026·2026-09-09

    Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software

    Boston Scientific is recalling LUX-Dx Insertable Cardiac Monitor server software due to potential delays in Atrial Fibrillation Burden Alert notifications, which may delay clinical evaluation.

    Product
    LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3082-2026·2026-09-09

    Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software

    Boston Scientific is recalling LUX-Dx Insertable Cardiac Monitor server software due to potential delays in Atrial Fibrillation Burden Alerts, which may delay clinical evaluation.

    Product
    LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2977-2026·2026-08-26

    Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation

    Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection Systems due to a potential for arterial sheath tip separation or partial tip separation during use.

    Product
    Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2962-2026·2026-08-26

    Boston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices

    Boston Scientific is recalling Suture Cinch Long endoscopic tissue approximation devices because they may fail to deploy the implant or cut the suture.

    Product
    Suture Cinch Long 1pk. Endoscopic tissue approximation device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2978-2026·2026-08-26

    Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall

    Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection System Plus catheters due to a potential for arterial sheath tip separation during use.

    Product
    Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2840-2026·2026-08-12

    Radial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall

    Boston Scientific is recalling Radial Jaw 4 Jumbo Biopsy Forceps due to potential breach in the sterile barrier of device packaging. The recall affects 5,020 units in the US and 20,770 units outside the US.

    Product
    Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2839-2026·2026-08-12

    Biopsy Forceps Recall: Sterile Packaging Breach Risk

    Boston Scientific is recalling Radial Jaw 4 Large Capacity Biopsy Forceps due to a potential breach in the sterile barrier of device packaging, which could compromise sterility.

    Product
    Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2838-2026·2026-08-12

    Boston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk

    Boston Scientific Corporation is recalling specific Radial Jaw 4 Standard Capacity Biopsy Forceps because there is a potential for a breach in the sterile barrier of the device packaging.

    Product
    Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2756-2026·2026-07-29

    Boston Scientific Steerable Sheath Recalled Due to Potential Air Embolism Risk

    Boston Scientific is recalling FARADRIVE STEERABLE SHEATH (CLEAR) because improper dilator insertion can damage the hemostatic valve, potentially leading to air ingress and air embolism.

    Product
    FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2753-2026·2026-07-29

    Boston Scientific Recalls FARASTAR Ablation Generators Due to Catheter Incompatibility

    Boston Scientific is replacing specific FARASTAR PFA generators that are not compatible with the FARAPOINT PFA catheter. The FDA Class II recall affects 6 units distributed internationally.

    Product
    FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2757-2026·2026-07-29

    Boston Scientific Steerable Sheath Recall Over Hemostatic Valve Damage

    Boston Scientific is recalling its Faradrive Steerable Sheath devices due to potential hemostatic valve damage during preparation, which may cause air ingress and patient harm.

    Product
    FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2771-2026·2026-07-29

    Boston Scientific TheraSphere 360 Y-90 Management Platform Software Recall Due to Calculation Error

    Boston Scientific Corporation is recalling the TheraSphere 360 Y-90 Management Platform (Model M00139509001) due to a software anomaly that may cause incorrect dose calculations.

    Product
    Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2754-2026·2026-07-29

    FARADRIVE Steerable Sheath Clear IDE Recall for Air Embolism Risk

    Boston Scientific recalls 400 units of a cardiac catheter sheath due to potential air embolism risk from valve damage during preparation.

    Product
    FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2755-2026·2026-07-29

    FARADRIVE STEERABLE SHEATH CLEAR Medical Device Recall

    Boston Scientific recalls FARADRIVE STEERABLE SHEATH CLEAR due to valve damage risk that could cause air embolism during heart procedures.

    Product
    FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2750-2026·2026-07-29

    FARASTAR Ablation Generator EU Medical Device Recall for Labeling Discrepancy

    Boston Scientific is recalling 18 FARASTAR Ablation Generator EU devices due to missing FARAPOINT PFA catheter information in the Instructions For Use.

    Product
    FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2752-2026·2026-07-29

    FARASTAR PFA Generator and Cardiac Ablation Catheter Recalled Due to Labeling Discrepancy

    Boston Scientific Corporation is recalling 11 units of FARASTAR PFA Generators and Percutaneous Cardiac Ablation Catheters because the Instructions For Use did not include FARAPOINT PFA catheter information.

    Product
    FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2751-2026·2026-07-29

    FARASTAR Cardiac Ablation Generator Recall for Missing Catheter Information

    Boston Scientific recalls cardiac ablation generators due to incomplete Instructions For Use that omit information about a compatible catheter.

    Product
    FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2725-2026·2026-07-22

    Rapid Refill Continuous Injection System Recalled for Syringe Loosening Risk

    Boston Scientific's Rapid Refill Continuous Injection System (UPN M00566001) is being recalled because the recalled Medline Namic Angiographic Control Syringe may loosen or disconnect from the manifold, potentially causing leakage, inability to aspirate or inject, and procedure delays.

    Product
    Rapid Refill Continuous Injection System, UPN M00566001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2632-2026·2026-07-08

    CRE Wireguided 6-8mm 240cm Medical Device Recall Worldwide

    Boston Scientific Corporation is recalling the CRE Wireguided 6-8mm 240cm device worldwide due to a potential sterile breach of the packaging pouches.

    Product
    CRE Wireguided 6-8mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2634-2026·2026-07-08

    Boston Scientific CRE Wireguided Medical Device Recall Sterile Breach

    Boston Scientific is recalling CRE Wireguided 10-12mm 240cm medical devices due to a potential sterile breach in the product packaging. The breach could compromise device sterility and affect patient safety.

    Product
    CRE Wireguided 10-12mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2631-2026·2026-07-08

    CRE Pro Wireguided esophageal stent device recalled for packaging sterility

    Boston Scientific is recalling CRE Pro Wireguided 18-20mm 240cm esophageal stents due to potential sterile breach of product pouches. The breach could allow contamination of sterile devices.

    Product
    CRE Pro Wireguided 18-20mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2626-2026·2026-07-08

    Boston Scientific CRE Pro Wireguided catheters recalled for packaging

    Boston Scientific is recalling CRE Pro Wireguided 6-8mm 240cm catheters worldwide due to a potential sterile breach in the packaging pouches, which could compromise device sterility.

    Product
    CRE Pro Wireguided 6-8mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2627-2026·2026-07-08

    CRE Pro Wireguided 8-10mm 240cm Medical Device Sterile Pouch Breach

    Boston Scientific is recalling CRE Pro Wireguided 8-10mm 240cm devices worldwide due to a potential sterile breach of the product packaging pouches. The breach could compromise the sterility of the devices.

    Product
    CRE Pro Wireguided 8-10mm 240cm
    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.