The Recall Desk

Manufacturer

Boston Scientific Corporation

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

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 336

  • 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-2637-2026·2026-07-08

    CRE Wireguided 18-20mm 240cm medical devices recalled for sterile breach

    Boston Scientific Corporation is recalling CRE Wireguided 18-20mm 240cm devices worldwide due to a potential sterile breach of the pouches in which the devices are packaged.

    Product
    CRE Wireguided 18-20mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2026·2026-07-08

    CRE Pro Wireguided medical device sterile packaging breach recall

    Boston Scientific Corporation is recalling the CRE Pro Wireguided 10-12mm 240cm device due to potential sterile breach of the pouches in which devices are packaged. The affected product has been distributed worldwide.

    Product
    CRE Pro Wireguided 10-12mm 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
  • HighFDA (Devices)·Z-2629-2026·2026-07-08

    Boston Scientific CRE Pro Wireguided 12-15mm Esophageal Stent Recall

    Boston Scientific is recalling CRE Pro Wireguided 12-15mm 240cm esophageal stents due to a potential sterile breach in the device packaging. Affected units were distributed worldwide.

    Product
    CRE Pro Wireguided 12-15mm 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-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
  • ModerateFDA (Devices)·Z-2633-2026·2026-07-08

    CRE Wireguided 8-10mm 240cm Medical Device Recall Notice

    Boston Scientific Corporation is recalling CRE Wireguided 8-10mm 240cm devices worldwide due to potential sterile breaches in the packaging pouches that could compromise device sterility.

    Product
    CRE Wireguided 8-10mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2630-2026·2026-07-08

    CRE Pro Wireguided Medical Device Recall for Sterile Packaging Breach

    Boston Scientific is recalling the CRE Pro Wireguided 15-18mm 240cm device due to a potential sterile breach of the product pouches. The breach may compromise device sterility.

    Product
    CRE Pro Wireguided 15-18mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2635-2026·2026-07-08

    CRE Wireguided Device Recall Due to Potential Sterile Packaging Breach

    Boston Scientific Corporation is recalling CRE Wireguided 12-15mm 240cm devices due to a potential sterile breach in the pouches containing the devices. The breach could compromise device sterility.

    Product
    CRE Wireguided 12-15mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2636-2026·2026-07-08

    CRE Wireguided 15-18mm 240cm Medical Device Sterile Pouch Breach

    Boston Scientific Corporation is recalling the CRE Wireguided 15-18mm 240cm device due to a potential sterile breach in the packaging pouches. The affected devices were distributed worldwide.

    Product
    CRE Wireguided 15-18mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2580-2026·2026-07-01

    Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall

    Boston Scientific Corporation is recalling the Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump (model AP-0300H) due to potential leakage along the drug pathway from the pump through the catheter.

    Product
    Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2026·2026-05-13

    LUX-DX II Arrhythmia Detector Monitoring Function Data Collection Issue

    Boston Scientific is recalling the LUX-DX II Model M302 and M312 arrhythmia detectors because some upgraded devices are not collecting PVC Burden data or monitoring for Bradyarrhythmia and Pause, with conflicting information shown in programming screens.

    Product
    LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2026·2026-05-13

    LUX-Dx II Plus Arrythmia Detector Software Monitoring Feature Failure

    Boston Scientific's LUX-Dx II Plus implantable cardiac monitors may fail to collect PVC Burden data or monitor for abnormal heart rhythms in some upgraded devices, creating potential gaps in patient monitoring.

    Product
    LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1771-2026·2026-05-06

    Boston Scientific Cardiac Pacemakers Require Software Update

    Boston Scientific is expanding a software advisory for ACCOLADE family pacemakers and cardiac resynchronization therapy devices. Updated software (Brady SMR6) is now available to address identified issues.

    Product
    Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Mod
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1770-2026·2026-05-06

    Boston Scientific Pacemakers Subject to Software Update Advisory

    Boston Scientific is issuing a software update (Brady SMR6) for certain ACCOLADE and PROPONENT pacemakers and cardiac resynchronization therapy devices. The advisory population is expanding to include all dual-chamber extended life and CRT-P devices.

    Product
    Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4. ESSENTIO
    Category
    Medical Device
    Distribution
    0 states