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 Dec 30, 2020 to Jan 27, 2021.

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 Jan 27, 2021

ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead i…

FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904

FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, M…

FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714729960928, M…

FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Mad…

FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Mad…

FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Mad…

FDA Devices Moderate Jan 13, 2021

Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation…

FDA Devices Moderate Jan 13, 2021

AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 …

FDA Devices Moderate Jan 13, 2021

Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation…

FDA Devices Moderate Jan 13, 2021

AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 …

FDA Devices Moderate Jan 13, 2021

Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation…

FDA Devices Moderate Jan 13, 2021

AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 …

FDA Devices Moderate Jan 6, 2021

Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190

FDA Devices Moderate Jan 6, 2021

Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570

FDA Devices Moderate Dec 30, 2020

IceSeed" 1.5 Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IcePearl" 2.1 CX 90¿ Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 CX 90¿ Cryoablation Needle¿

FDA Devices Moderate Dec 30, 2020

Five IceSphere" Prostate Cryoablation Kit

FDA Devices Moderate Dec 30, 2020

IcePearl" 2.1 CX Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 i-Thaw" Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceSeed" 1.5 90¿ Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceSeed" 1.5 MRI Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceSphere" 1.5 CX 90¿ Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceSphere" 1.5 Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceSphere" 1.5 S 90¿ Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceFORCE" 2.1 CX 90¿ Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 PLUS 90¿ Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

Five IceRod" i-Thaw" Prostate Cryoablation Kit

FDA Devices Moderate Dec 30, 2020

IceEDGE" 2.4¿ 90p¿ Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceSeed" Prostate Cryoablation Kit

FDA Devices Moderate Dec 30, 2020

Three IcePearl" 2.1 CX Prostate Cryoablation Kit

FDA Devices Moderate Dec 30, 2020

IcePearl" 2.1 CX L 90¿ Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 MRI Cryoablation Needle¿

FDA Devices Moderate Dec 30, 2020

IceFORCE" 2.1 CX Prostate Cryoablation Kit

FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 90¿ Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

Three IceFORCE" 2.1 CX Prostate Cryoablation Kit

FDA Devices Moderate Dec 30, 2020

IceSphere" 1.5 90¿ Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 PLUS Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceRod" Prostate Cryoablation Kit

FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceRod" i-Thaw" Prostate Cryoablation Kit

FDA Devices Moderate Dec 30, 2020

IceFORCE" 2.1 CX Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceSphere" 1.5 Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceFORCE" 2.1 CX L 90¿ Cryoablation Needle

FDA Devices Moderate Dec 30, 2020

IceRod" He-Thaw Prostate Cryoablation Kit

FDA Devices Moderate Dec 30, 2020

IceSeed" Prostate Cryoablation Kit

FDA Devices Moderate Dec 30, 2020

IceRod" i-Thaw" Prostate Cryoablation Kit

FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 MRI 90¿ Cryoablation Needle¿

FDA Devices Moderate Dec 30, 2020

IcePearl" 2.1 CX Prostate Cryoablation Kit

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.