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 Boston Scientific Coyote Over-the-Wire PTA Balloon Dilation Catheter is used in medical procedures to dilate blood vessels. Healthcare providers typically use these devices for angioplasty to treat narrowed or blocked blood vessels.
The defect in the manufacturing process can lead to difficulties in inflating or deflating the catheter. This can hinder the intended medical procedure and pose significant risks to patient health.
This recall is not part of a broader industry pattern.
Patients relying on these devices for medical treatment face serious risks if they continue to use the recalled catheters. Immediate action is required to ensure patient safety.
Look for the model number and manufacturing date on the catheter packaging or the product itself, typically located on the labels.
Expect a timeline of 4-6 weeks for processing refunds or replacements once the return is initiated.
Keep records of all communications regarding the recall, including receipts and photos of the device.
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.
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