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 |
|---|---|---|---|
| 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 |
| Aug 28, 2025 | Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12m... | The product in incorrectly labeled. The label indicates that the skive hole s... | Class II |
| Aug 20, 2025 | ACCOLADE DR SL MRI (Model L311) | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number S722, ALTRUA 2 DR EL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | PROPONENT DR SL (Model L201) | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | ACCOLADE SR SL MRI (Model L310) | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number L100, ESSENTIO SR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number U125, VALITUDE CRT-P EL | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | ACCOLADE SR SL (Model L300) | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number L111, ESSENTIO DR SL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number S701 ALTRUA 2 SR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | ACCOLADE DR EL (Model L321) | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | ACCOLADE DR SL (Model L301) | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number L210 PROPONENT SR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number U225 VISIONIST CRT-P EL | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number L110, ESSENTIO SR SL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | ACCOLADE DR EL MRI (Model L331) | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number L131, ESSENTIO DR EL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number U228, VISIONIST CRT-P EL MRI | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number L101, ESSENTIO DR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number L231, PROPONENT DR EL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number U128, VALITUDE CRT-P EL MRI | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number L211 PROPONENT DR SL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number L121 ESSENTIO DR EL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number L221 PROPONENT DR EL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | PROPONENT SR SL (Model L200) | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number U226, VISIONIST CRT-P EL | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number L209 PROPONENT DR (VDD) SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 20, 2025 | Model Number S702, ALTRUA 2 DR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent ... | Class I |
| Aug 18, 2025 | Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000 | Certain desiccant tube subassemblies were built with end caps that were not c... | Class II |
| Aug 18, 2025 | ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Ma... | Certain desiccant tube subassemblies were built with end caps that were not c... | Class II |
| Aug 5, 2025 | Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H749045... | The Encore 26 Inflation Device is used with balloon dilation catheters to cre... | Class II |
| Aug 5, 2025 | Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H... | The Encore 26 Inflation Device is used with balloon dilation catheters to cre... | Class II |
| Aug 5, 2025 | Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200... | The Encore 26 Inflation Device is used with balloon dilation catheters to cre... | Class II |
| Aug 5, 2025 | Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; ... | The Encore 26 Inflation Device is used with balloon dilation catheters to cre... | Class II |
| Jul 29, 2025 | WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; i... | Boston Scientific has identified a higher likelihood of air embolism events w... | Class I |
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.
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