Boston Scientific Recalls

45 recalls found for Boston Scientific. Check if any of your products are affected.

HIGH
FDA DEVICE

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,...

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.

Boston Scientific
For some
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HIGH
FDA DEVICE

LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.

Boston Scientific
For some
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HIGH
FDA DEVICE

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...

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia

Boston Scientific
Updated software,
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HIGH
FDA DEVICE

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...

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia

Boston Scientific
Updated software,
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific EndoVive PEG Kit Recalled for Sterility Risk in 806 Kits (2026)

Boston Scientific is recalling 806 EndoVive Safety PEG Kits sold nationwide. The recall concerns BD ChloraPrep Triple Swabsticks with open or compromised seals that could compromise sterility or dry the antiseptic solution. Hospitals and patients should stop using the kits immediately and follow the manufacturer's recall instructions.

Boston Scientific
Recall of
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls AXIOS Stent Over Deployment Issues

Boston Scientific recalled 39 AXIOS Stent and Electrocautery-Enhanced Delivery Systems on December 19, 2025. Reports indicated issues with stent deployment and expansion, potentially leading to additional surgical interventions. The recall affects units distributed worldwide, including the United States and several other countries.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Stent Recalled Over Deployment Issues

Boston Scientific recalled 59 AXIOS Stents on December 19, 2025. Increased reports of deployment and expansion issues pose serious risks during procedures. Users should stop using the devices immediately and follow recall instructions.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls Stent System Due to Deployment Issues

Boston Scientific recalled 150 units of its *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. The recall follows increased reports of stent deployment and expansion issues, which could lead to serious medical interventions. Healthcare providers and patients must stop using the device immediately.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls HOT AXIOS Stent Over Deployment Issues

Boston Scientific recalled 266 units of the HOT AXIOS Stent on December 19, 2025. Reports indicated deployment and expansion problems, posing risks of prolonged procedures and additional surgical interventions. Consumers must stop using the device immediately and follow the manufacturer's instructions.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Issues Recall for Stent Due to Deployment Issues

Boston Scientific recalled 588 units of its *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. The recall follows multiple reports of stent deployment and expansion issues, posing serious risks during medical procedures.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls AXIOS Stent Due to Deployment Risks

Boston Scientific recalled 557 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. Increased reports of stent deployment and expansion issues prompted this recall. The defect may require additional medical intervention to resolve deployment failures.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls Balloon Catheters Over Inflation Issues

Boston Scientific recalled 21,000 Coyote Over-the-Wire PTA Balloon Dilation Catheters on December 3, 2025. The recall affects devices that may not properly inflate or deflate, posing a risk during medical procedures. Patients and healthcare providers should stop using these devices immediately and follow the recall instructions.

Boston Scientific
Boston Scientific
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific TENACIO Pump Recall 2025 for Inflation Deflation Issues

Boston Scientific recalled the TENACIO Pump without InhibiZone (UPN 72404420) worldwide, including the US and Canada. The device may experience inflation and/or deflation performance issues. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions.

Boston Scientific
The potential
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific LGX Preconnect with TENACIO Pump Recalled for Inflation/Deflation Issues (2025)

Boston Scientific recalled two UPN configurations of the LGX Preconnect with TENACIO Pump without InhibiZone due to potential inflation and deflation performance issues. The devices were distributed worldwide, including the US and Canada. Healthcare providers are instructed to stop use and follow manufacturer recall instructions.

Boston Scientific
The potential
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific CX Preconnect with TENACIO Pump Recall for Inflation Issues (2025)

Boston Scientific is recalling 1 CX Preconnect with TENACIO Pump sold to healthcare providers worldwide, including the US and Canada. The device may experience inflation and/or deflation performance issues. Healthcare providers and patients should stop using the device and follow manufacturer recall instructions.

Boston Scientific
The potential
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recall: Preconnect with TENACIO Pump with InhibiZone Affects 172 Units Worldwide

Boston Scientific recalled 172 units of the CXR Preconnect with TENACIO Pump with InhibiZone worldwide. The recall was initiated on 2025-09-11 and remains active as of 2025-10-22. The devices can experience inflation and/or deflation performance issues. Healthcare providers should stop using the devices and follow manufacturer instructions for recall remediation.

Boston Scientific
The potential
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Extractor Pro RX Balloon Catheter Recalled Over Labeling Error (2025)

Boston Scientific recalled 156 units of the Extractor Pro RX Retrieval Balloon Catheter nationwide in the United States after labeling inconsistencies were found. The label misstates whether the skive hole is above or below the balloon. The recall is active as of 2025. Stop using the device immediately and follow manufacturer instructions.

Boston Scientific
The product
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recall 28,911 U128 ACCOLADE, VISIONIST VALITUDE CRT-P Devices (2025)

Boston Scientific recalled 28,911 pacemakers worldwide due to a software flaw in Safety Architecture that could prevent Safety Mode when battery impedance is high. The recall covers ACCOLADE family devices and VISIONIST and VALITUDE CRT-Ps. Patients should stop using the device immediately and follow the recall letter instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific L211 PROPONENT DR SL MRI Pacemakers Recalled Worldwide (106,536 Units, 2025)

Boston Scientific recalls 106,536 ACCOLADE family pacemakers sold worldwide through healthcare providers. The recall centers on software designed to strengthen Safety Architecture that could prevent initiating Safety Mode in patients with a high battery impedance state. Patients should stop using the device immediately and contact their clinician or Boston Scientific for instructions.

Boston Scientific
Software to
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Brand Statistics

Total Recalls
45
Pages
3

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