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 6 critical, 44 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 Oct 2, 2024 to Nov 20, 2024.

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 Nov 20, 2024

Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060

FDA Devices Critical Nov 20, 2024

Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160

FDA Devices Critical Nov 20, 2024

Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110

FDA Devices Critical Nov 20, 2024

Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPIT…

FDA Devices Critical Nov 20, 2024

Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010

FDA Devices Critical Nov 20, 2024

Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.

FDA Devices Moderate Oct 30, 2024

Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive display to prov…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provid…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provide physicians…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians wi…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display to provide p…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to provide physici…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive display to prov…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provid…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an interactive display to provi…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive display to provi…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactive display to provide physicia…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive display to provide physicians wi…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW; the system utilizes an interactive display to provide ph…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide phy…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provid…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW; the system utilizes an interactive display to provi…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US; the system utilizes an interactive display to provide p…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the system utilizes an interactive display to provide physicians…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW; the system utilizes an interactive display to provide physici…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system utilizes an interactive display to provid…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US; the system utilizes an interactive display to provide p…

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; the system utilizes an interactive display to provide p…

FDA Devices Moderate Oct 2, 2024

WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophage…

FDA Devices Moderate Oct 2, 2024

AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaini…

FDA Devices Moderate Oct 2, 2024

WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …

FDA Devices Moderate Oct 2, 2024

WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal lumi…

FDA Devices Moderate Oct 2, 2024

WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal …

FDA Devices Moderate Oct 2, 2024

WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal lumin…

FDA Devices Moderate Oct 2, 2024

WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …

FDA Devices Moderate Oct 2, 2024

WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophagea…

FDA Devices Moderate Oct 2, 2024

WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophagea…

FDA Devices Moderate Oct 2, 2024

AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining…

FDA Devices Moderate Oct 2, 2024

WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophagea…

FDA Devices Moderate Oct 2, 2024

WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …

FDA Devices Moderate Oct 2, 2024

WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal…

FDA Devices Moderate Oct 2, 2024

WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …

FDA Devices Moderate Oct 2, 2024

AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining…

FDA Devices Moderate Oct 2, 2024

WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal…

FDA Devices Moderate Oct 2, 2024

WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal lumi…

FDA Devices Moderate Oct 2, 2024

WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esop…

FDA Devices Moderate Oct 2, 2024

WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esoph…

FDA Devices Moderate Oct 2, 2024

WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophage…

FDA Devices Moderate Oct 2, 2024

WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Boston Scientific Corporation with Zimmer Biomet, Inc. →

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.