PlainRecalls

Boston Scientific Corporation

413 recalls on record · Latest: Feb 11, 2026

Boston Scientific Corporation Recall Insight

Boston Scientific Corporation appears on 413 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.492% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 11, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 26 critical, 24 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Feb 5, 2025 to Feb 11, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Critical Feb 11, 2026

HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;

FDA Devices Critical Feb 11, 2026

AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;

FDA Devices Critical Feb 11, 2026

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;

FDA Devices Critical Feb 11, 2026

AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;

FDA Devices Critical Oct 22, 2025

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Devices Critical Oct 22, 2025

Model Number S702, ALTRUA 2 DR SL Pacemaker

FDA Devices Critical Oct 22, 2025

Model Number U128, VALITUDE CRT-P EL MRI

FDA Devices Critical Oct 22, 2025

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Devices Moderate Oct 22, 2025

TENACIO Pump without InhibiZone; UPN: 72404420;

FDA Devices Critical Oct 22, 2025

Model Number L101, ESSENTIO DR SL Pacemaker

FDA Devices Critical Oct 22, 2025

Model Number L209 PROPONENT DR (VDD) SL Pacemaker

FDA Devices Critical Oct 22, 2025

Model Number U226, VISIONIST CRT-P EL

FDA Devices Moderate Oct 22, 2025

TENACIO Pump with InhibiZone; UPN: 72404429;

FDA Devices Critical Oct 22, 2025

PROPONENT SR SL (Model L200)

FDA Devices Critical Oct 22, 2025

Model Number U228, VISIONIST CRT-P EL MRI

FDA Devices Moderate Oct 22, 2025

LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);

FDA Devices Critical Oct 22, 2025

Model Number L221 PROPONENT DR EL Pacemaker

FDA Devices Critical Oct 22, 2025

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Devices Critical Oct 22, 2025

ACCOLADE DR EL MRI (Model L331)

FDA Devices Critical Oct 22, 2025

Model Number L121 ESSENTIO DR EL Pacemaker

FDA Devices Critical Oct 22, 2025

Model Number L110, ESSENTIO SR SL MRI Pacemaker

FDA Devices Moderate Oct 1, 2025

Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

FDA Devices Moderate Sep 17, 2025

Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)

FDA Devices Moderate Sep 17, 2025

ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000

FDA Devices Moderate Sep 17, 2025

Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

FDA Devices Moderate Sep 17, 2025

Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240…

FDA Devices Moderate Sep 17, 2025

Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. …

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left …

FDA Devices Critical Sep 10, 2025

WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WA…

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left …

FDA Devices Critical Sep 10, 2025

WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATC…

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left…

FDA Devices Critical Sep 10, 2025

WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATC…

FDA Devices Critical Aug 27, 2025

ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, …

FDA Devices Critical Aug 27, 2025

RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658…

FDA Devices Moderate Aug 20, 2025

FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401

FDA Devices Moderate Jul 16, 2025

Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the pe…

FDA Devices Moderate Jul 16, 2025

VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VX…

FDA Devices Moderate Jul 16, 2025

VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized…

FDA Devices Moderate Jul 16, 2025

VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J …

FDA Devices Moderate May 7, 2025

IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Fr…

FDA Devices Moderate May 7, 2025

IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Free…

FDA Devices Moderate May 7, 2025

IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Fre…

FDA Devices Moderate Feb 5, 2025

AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740

FDA Devices Moderate Feb 5, 2025

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

FDA Devices Moderate Feb 5, 2025

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560

FDA Devices Moderate Feb 5, 2025

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550

FDA Devices Moderate Feb 5, 2025

AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650

FDA Devices Moderate Feb 5, 2025

AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670

FDA Devices Moderate Feb 5, 2025

AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Boston Scientific Corporation with FORD →

Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds