41 recalls found for Boston Scientific. Check if any of your products are affected.
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 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 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 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 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 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 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 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 recalled 59 Tenacio Pumps with InhibiZone worldwide, including the US and Canada. The devices may experience inflation and/or deflation performance issues. Patients and healthcare providers should stop using the device immediately and await recall instructions.
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 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 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 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 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 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 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 recalled 61,700 pacemakers worldwide after a software issue was identified. The device safety architecture could fail to initiate Safety Mode when battery impedance is high. Healthcare providers were advised to stop using the affected devices and follow recall instructions from the manufacturer.
Boston Scientific is recalling 3,592 pacemakers sold worldwide through hospitals and clinics in 2025. A software feature intended to enhance Safety Architecture may fail to initiate Safety Mode in ambulatory settings due to high battery impedance. Patients and healthcare providers should stop using these devices immediately and follow the recall instructions.
Boston Scientific recalled 1,050 pacemaker units worldwide on Aug 20, 2025. The recall covers ACCOLADE family devices and Visionist and Valitude CRT-Ps. A software issue could prevent Safety Mode initiation in ambulatory settings. Patients should follow manufacturer guidance and contact their clinician immediately.
Boston Scientific recalled 1,380 pacemakers worldwide on August 20, 2025, due to software intended to enhance Safety Architecture. The devices include ACCOLADE family models and VISIONIST and VALITUDE CRT-Ps. The defect could prevent initiation of Safety Mode in ambulatory settings. Patients should stop using the devices and follow manufacturer instructions.