Boston Scientific recalled 21,000 Coyote Over-the-Wire PTA Balloon Dilation Catheters on December 3, 2025. The recall affects devices that may not properly inflate or deflate, posing a risk during medical procedures. Patients and healthcare providers should stop using these devices immediately and follow the recall instructions.
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
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The recall involves Boston Scientific Coyote Over-the-Wire PTA Balloon Dilation Catheters, specifically models REF H74939186251210 and REF H74939186351210. These were distributed nationwide across multiple states including MA, WV, OH, CA, MN, NY, VA, IL, TX, and FL. The devices were manufactured between September 12, 2025, and October 13, 2025.
The recalled catheters may experience difficulties in inflation and deflation during use, which can lead to complications in peripheral vascular procedures. This poses a serious risk of inadequate dilation and potential medical emergencies.
Patients and healthcare providers should immediately stop using the affected catheters. Follow the recall instructions from Boston Scientific and contact them directly or your healthcare provider for guidance.
For more information, contact Boston Scientific Corporation. Visit their website or call for specific recall instructions.
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