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Boston Scientific Corporation

Boston Scientific Corporation Recalls

All product recalls associated with Boston Scientific Corporation.

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Recall Summary

Total Recalls

1000

Past Year

567

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 721–740 of 7756 recalls

Agile ESO OTW FC 23mm 10.1cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO FC RMV 23mm 10.1cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

WallFlex Esophageal FC 23/28mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

1...35 363738 39...388

Page 37 of 388Next

FDA

Aug 1, 2024

Nationwide

• Boston Scientific Corporation

WallFlex Esophageal FC 18/23-25mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

WallFlex PC Esoph Stent 18/23mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

WallFlex ESO Stent 23x105mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Heparin Sodium Injection (Baxter) – Endotoxin Contamination (2024)

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Class IHigh

FDAAug 1, 2024Nationwide• Baxter Healthcare Corporation

WallFlex ESO Stent LL 18x103 (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW PC 23mm 12.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW PC 23mm 15.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

IMMAGE IGM Immunoglobulin M Reagent (Beckman Coulter) – Sensitivity Issue (2024)

Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU

FDAJul 31, 2024AZ, CA, CO +12 more• Beckman Coulter Inc.

Boars Head Grab and Go Ham (Publix) – listeria risk (2024)

Listeria

Potential Listeria Monocytogenes

Class IHigh

FDAJul 30, 2024FL, GA, IN• Publix Super Markets, Inc.

CustomEyes Procedure Packs (Beaver Visitec) – Syringe Recall (2024)

Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.

FDAJul 26, 2024Nationwide• Beaver Visitec International, Inc.

BiomarC EX Fiducial Marker System, Catalog Number 040165 (Carbon Medical Technologies, Inc.) – this recall has been initiated due to... (2024)

This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.

FDAJul 26, 2024Nationwide• Carbon Medical Technologies, Inc.

CustomEyes Procedure Packs (Beaver Visitec) – Syringe Recall (2024)

Data in RES.

FDAJul 26, 2024Nationwide• Beaver Visitec International, Inc.

Cinnamon Powder (Alb-USA) – High Lead Levels (2024)

Product contains elevated levels of lead (3.294ppm)

Class IIModerate

FDAJul 25, 2024CT, MA, MI +1 more• Alb-USA Enterprises Inc

CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number... (Schiller, Ag Altgasse 68 Baar Switzerland) – potential for high-frequency signal a... (2024)

Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.

FDAJul 24, 2024FL, IN• Schiller, Ag Altgasse 68 Baar Switzerland

FreeStyle Libre 3 Sensors, REF: 72081-01, component of th... (Abbott Diabetes Care, Inc.) – laceration hazard (2024)

Laceration Risk

Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with significant adverse health consequences. Such consequences include central nervous system dysfunction, loss of consciousness, seizure activity and may lead to coma, permanent neurological damage, and death.

FDAJul 24, 2024CA, FL, MN +9 more• Abbott Diabetes Care, Inc.

Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia... (Mindray DS USA, Inc. dba Mindray North America) – v90 electronic vaporizer anesthetic a... (2024)

V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention

FDAJul 22, 2024CA, GA, KY +6 more• Mindray DS USA, Inc. dba Mindray North America

Isoflurane E_Vap.(Safety Filling adapter): used with the ... (Mindray DS USA, Inc. dba Mindray North America) – v90 electronic vaporizer anesthetic a... (2024)

FDAJul 22, 2024CA, GA, KY +6 more• Mindray DS USA, Inc. dba Mindray North America