Boston Scientific Corporation

Complete recall history across all FDA and CPSC categories, 601 total recalls

Boston Scientific Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (601)

FDA medical device enforcement actions by Boston Scientific Corporation. Showing most recent 50.

Date Product Reason Class
Jul 14, 2026 Suture Cinch Long 1pk. Endoscopic tissue approximation device. Device may fail to deploy the cinch implant and/or fail to cut the suture as ... Class II
Jul 14, 2026 OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device. Device may fail to deploy the cinch implant and/or fail to cut the suture as ... Class II
Jul 9, 2026 Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Numb... Potential for arterial sheath tip separation or partial tip separation during... Class I
Jul 9, 2026 Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material... Potential for arterial sheath tip separation or partial tip separation during... Class I
Jun 30, 2026 Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions... Potential for breach in sterile barrier of device packaging. Class II
Jun 30, 2026 Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions an... Potential for breach in sterile barrier of device packaging. Class II
Jun 30, 2026 Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: ... Potential for breach in sterile barrier of device packaging. Class II
Jun 30, 2026 Rapid Refill Continuous Injection System, UPN M00566001 Devices contain recalled Medline Namic Angiographic Control Syringe with Rota... Class II
Jun 19, 2026 Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M001... Software anomaly occurs when a user adds one or more vials to the cart and su... Class II
Jun 11, 2026 FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vas... Boston Scientific's complaint investigations have identified that a subset of... Class II
Jun 11, 2026 FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vascul... Boston Scientific's complaint investigations have identified that a subset of... Class II
Jun 11, 2026 FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vascul... Boston Scientific's complaint investigations have identified that a subset of... Class II
Jun 11, 2026 FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablat... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) di... Class II
Jun 11, 2026 FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutan... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) di... Class II
Jun 11, 2026 FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 6... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) di... Class II
Jun 11, 2026 FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 6... Boston Scientific is replacing specific FARASTAR PFA generators which have a ... Class II
Jun 11, 2026 FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculatur... Boston Scientific's complaint investigations have identified that a subset of... Class II
May 21, 2026 CRE Pro Wireguided 18-20mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II
May 21, 2026 CRE Wireguided 10-12mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II
May 21, 2026 CRE Pro Wireguided 8-10mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II
May 21, 2026 CRE Wireguided 18-20mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II
May 21, 2026 CRE Wireguided 6-8mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II
May 21, 2026 CRE Wireguided 15-18mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II
May 21, 2026 CRE Wireguided 12-15mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II
May 21, 2026 CRE Wireguided 8-10mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II
May 21, 2026 CRE Pro Wireguided 6-8mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II
May 21, 2026 CRE Pro Wireguided 15-18mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II
May 21, 2026 CRE Pro Wireguided 10-12mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II
May 21, 2026 CRE Pro Wireguided 12-15mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II
May 12, 2026 Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-5... Boston Scientific is initiating a medical device removal of Orca Sterile, Si... Class II
May 11, 2026 Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantab... There is the potential for leakage along the drug pathway from the pump throu... Class II
Mar 30, 2026 LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATI... For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M... Class II
Mar 30, 2026 LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE ... For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M... Class II
Mar 19, 2026 Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Car... Updated software, Brady software maintenance release 6 (SMR6), is now availab... Class I
Mar 19, 2026 Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VA... Updated software, Brady software maintenance release 6 (SMR6), is now availab... Class I
Feb 10, 2026 EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner ... Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or c... Class II
Dec 19, 2025 AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Materia... Increased reports of stent deployment and expansion issues. The most common o... Class I
Dec 19, 2025 *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Ma... Increased reports of stent deployment and expansion issues. The most common o... Class I
Dec 19, 2025 AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Materia... Increased reports of stent deployment and expansion issues. The most common o... Class I
Dec 19, 2025 *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; ... Increased reports of stent deployment and expansion issues. The most common o... Class I
Dec 19, 2025 AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Mater... Increased reports of stent deployment and expansion issues. The most common o... Class I
Dec 19, 2025 HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Mat... Increased reports of stent deployment and expansion issues. The most common o... Class I
Dec 3, 2025 Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1... Boston Scientific is initiating the removal of certain batches of Coyote" Ove... Class II
Sep 11, 2025 CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12... The potential for devices to experience inflation and/or deflation performanc... Class II
Sep 11, 2025 LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (1... The potential for devices to experience inflation and/or deflation performanc... Class II
Sep 11, 2025 CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM... The potential for devices to experience inflation and/or deflation performanc... Class II
Sep 11, 2025 CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (1... The potential for devices to experience inflation and/or deflation performanc... Class II
Sep 11, 2025 LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12C... The potential for devices to experience inflation and/or deflation performanc... Class II
Sep 11, 2025 TENACIO Pump with InhibiZone; UPN: 72404429; The potential for devices to experience inflation and/or deflation performanc... Class II
Sep 11, 2025 TENACIO Pump without InhibiZone; UPN: 72404420; The potential for devices to experience inflation and/or deflation performanc... Class II

View all 601 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious, there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious, the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.