The Recall Desk

Manufacturer

Boston Scientific Corporation

321 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 321

  • 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
  • HighFDA (Devices)·Z-1551-2026·2026-03-18

    EndoVive Safety PEG Kit Recall Due to Compromised Swabstick Packaging

    Boston Scientific is recalling EndoVive Safety PEG Kits due to open or compromised seals on included ChloraPrep Triple Swabsticks that could result in loss of sterility or drying of antiseptic solution.

    Product
    EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1163-2026·2026-02-11

    Boston Scientific AXIOS Stent Deployment and Expansion Issues Recall

    Boston Scientific is recalling 588 units of HOT AXIOS biliary stents worldwide due to reports of deployment and expansion failures that may require additional endoscopic or surgical intervention.

    Product
    *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1160-2026·2026-02-11

    AXIOS Stent Deployment and Expansion Failures Require Device Exchange or Removal

    FDA Class I recall of AXIOS Stents due to reported deployment and expansion failures. Affected patients may require device exchange or additional surgical intervention to remove the stent and close the puncture site.

    Product
    AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1162-2026·2026-02-11

    HOT AXIOS stent delivery system recalled due to deployment and expansion issues

    Boston Scientific recalls HOT AXIOS 8mm stent delivery system for deployment and expansion failures. The devices may require surgical intervention to remove the stent and close puncture sites.

    Product
    *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1158-2026·2026-02-11

    AXIOS Stent Deployment System Recalled Due to Deployment and Expansion Failures

    Boston Scientific is recalling the AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm) due to reports of stent deployment and expansion failures that may require additional surgical or endoscopic intervention.

    Product
    AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1159-2026·2026-02-11

    Boston Scientific AXIOS Stent Deployment and Expansion Failure Recall

    Boston Scientific is recalling AXIOS stents due to reported deployment and expansion issues. The devices may fail to expand properly during procedures, potentially requiring additional surgical intervention.

    Product
    AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1161-2026·2026-02-11

    HOT AXIOS Stent Deployment and Expansion Issues FDA Class I Recall

    Boston Scientific is recalling 266 units of the HOT AXIOS Stent due to deployment and expansion issues that may require additional surgical intervention to remove the stent and close the puncture site.

    Product
    HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1042-2026·2026-01-21

    Boston Scientific Coyote Balloon Dilation Catheter Inflation Deflation Failure

    Boston Scientific is recalling certain batches of Coyote Over-the-Wire Balloon Dilation Catheters that may not properly inflate or deflate during use in peripheral vessels.

    Product
    Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0094-2026·2025-10-22

    Boston Scientific Pacemaker Software Update to Prevent Safety Mode

    Boston Scientific is issuing a software update for ACCOLADE family pacemakers to prevent improper Safety Mode activation related to high battery impedance in ambulatory settings. The update affects approximately 61,700 units of multiple pacemaker models distributed worldwide.

    Product
    Model Number L110, ESSENTIO SR SL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0087-2026·2025-10-22

    Boston Scientific Pacemaker Safety Mode Software Update Recall

    Boston Scientific is recalling certain pacemaker models due to potential inappropriate Safety Mode initiation in ambulatory settings. A software update is available to address a high battery impedance issue.

    Product
    Model Number L209 PROPONENT DR (VDD) SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0104-2026·2025-10-22

    Boston Scientific Pacemakers Recalled for Battery Impedance Software Issue

    Boston Scientific is recalling 1,050 pacemaker and cardiac resynchronization therapy devices worldwide due to potential high battery impedance causing unwanted Safety Mode activation. Software to prevent this issue is available.

    Product
    Model Number U226, VISIONIST CRT-P EL
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0103-2026·2025-10-22

    Pacemaker Recall: Boston Scientific VISIONIST CRT-P for Safety Mode Malfunction

    Boston Scientific's VISIONIST CRT-P pacemakers recalled due to unintended Safety Mode activation from high battery impedance. Software update is available to prevent the malfunction.

    Product
    Model Number U225 VISIONIST CRT-P EL
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0084-2026·2025-10-22

    Pacemaker Software Update to Prevent Unintended Safety Mode Activation

    Boston Scientific is recalling certain pacemakers due to potential unintended Safety Mode activation. A software update is available to address the issue in over 34,000 affected devices.

    Product
    ACCOLADE DR EL MRI (Model L331)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0090-2026·2025-10-22

    Pacemakers Software Update Required to Prevent Unintended Safety Mode

    Boston Scientific issued a Class I recall for multiple pacemaker models due to potential unintended Safety Mode initiation during high battery impedance conditions. Software is available to prevent this.

    Product
    Model Number L221 PROPONENT DR EL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0089-2026·2025-10-22

    Multiple Boston Scientific Pacemaker Models Recalled for Safety Software Issue

    Boston Scientific pacemakers may inappropriately activate Safety Mode in ambulatory settings due to high battery impedance. A software update is available to address this issue.

    Product
    Model Number L211 PROPONENT DR SL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0079-2026·2025-10-22

    Boston Scientific Recalls ACCOLADE Family Pacemakers for Safety Mode Software Defect

    Boston Scientific is recalling ACCOLADE pacemakers due to a software defect that may cause unintended Safety Mode activation when battery impedance is elevated. A software update is available to address this issue.

    Product
    ACCOLADE SR SL (Model L300)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0093-2026·2025-10-22

    ESSENTIO DR SL Pacemaker Safety Mode Software Recall

    Boston Scientific is recalling ESSENTIO DR SL and related pacemakers that may inappropriately enter Safety Mode due to high battery impedance. A software update has been released to prevent this condition.

    Product
    Model Number L101, ESSENTIO DR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0088-2026·2025-10-22

    Boston Scientific Pacemakers Software Update for Safety Mode

    Boston Scientific is issuing a software update for multiple pacemaker models to prevent unwanted Safety Mode activation due to high battery impedance in ambulatory settings. The update affects ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2, VISIONIST, and VALITUDE models distributed worldwide.

    Product
    Model Number L210 PROPONENT SR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0100-2026·2025-10-22

    Boston Scientific Pacemakers Software Issue Can Trigger Inappropriate Safety Mode

    Boston Scientific is recalling certain ACCOLADE family pacemakers, including ALTRUA 2 models, because a software issue can cause inappropriate Safety Mode activation in ambulatory settings. A software update is available to prevent this malfunction.

    Product
    Model Number S722, ALTRUA 2 DR EL Pacemaker
    Category
    Medical Device
    Distribution
    0 states