Boston Scientific Corporation recalls WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for…
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in…
Read the official notice →- Date
- 2025-09-10
- Country
- United States
- Brand
- Boston Scientific
- Product
- WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all…
- Classification
- Class I
- Units
- Worldwide.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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- 2025-10-01
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Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
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Boston Scientific Corporation recalls Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material…
- 2025-08-27
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Boston Scientific Corporation recalls ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282,…
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or…
FDA · DeviceBoston Scientific CorporationWorldwide Distribution. US nationwide. International distribution worldwide.Official notice → - 2025-08-20
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Boston Scientific Corporation recalls FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
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Boston Scientific Corporation recalls Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers:…
Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the…
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Other drugs & medical recalls in the United States
- 2025-09-10
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Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
The catheters may not retain their shape.
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mo-Vis BVBA recalls IDM-MICRO-R. Electrical wheelchair component.
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon…
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Dexcom, Inc. recalls Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software…
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App…
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FDA · DeviceBaxter Healthcare CorporationUS distribution including Puerto Rico and OUS (International) CanadaOfficial notice → - US
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