PlainRecalls

Boston Scientific Corporation

Compiled from official public sources by the editorial team.

605 recalls on record · Latest: May 13, 2026

Boston Scientific Corporation Recall Insight

Boston Scientific Corporation appears on 605 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.595% 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 May 13, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 22 critical, 28 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 Nov 20, 2024 to Sep 17, 2025.

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 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 Moderate Sep 17, 2025

Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral…

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 Sep 10, 2025

WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN…

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left…

FDA Devices Critical Sep 10, 2025

WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of W…

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left …

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left…

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 Critical Aug 27, 2025

ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 01…

FDA Devices Moderate Aug 20, 2025

FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401

FDA Devices Critical Aug 20, 2025

Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 …

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 May 7, 2025

IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freez…

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

FDA Devices Moderate Feb 5, 2025

AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640

FDA Devices Moderate Feb 5, 2025

AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690

FDA Devices Moderate Feb 5, 2025

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530

FDA Devices Moderate Feb 5, 2025

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570

FDA Devices Moderate Feb 5, 2025

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520

FDA Devices Moderate Feb 5, 2025

AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750

FDA Devices Moderate Feb 5, 2025

AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660

FDA Devices Critical Jan 22, 2025

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model N…

FDA Devices Critical Jan 22, 2025

VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)

FDA Devices Critical Jan 22, 2025

ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)

FDA Devices Critical Jan 22, 2025

ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)

FDA Devices Critical Jan 22, 2025

VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)

FDA Devices Critical Jan 22, 2025

ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)

FDA Devices Moderate Dec 4, 2024

AMS Artificial Urinary Sphincter Control Pump

FDA Devices Moderate Dec 4, 2024

AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O

FDA Devices Critical Nov 20, 2024

Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.