Boston Scientific Coyote PTA Balloon Catheter recalled for inflation/deflation difficulty
What this means
Boston Scientific found that certain batches of Coyote Over-the-Wire PTA Balloon Dilation Catheters may not inflate or deflate properly during use due to a manufacturing process variation. The issue affects only catheters made between September 12 and October 13, 2025. The company has corrected the manufacturing process.
- Check if your facility has either batch 37370117 (2.5mm x 120mm) or batch 37416646 (3.5mm x 120mm) with expiration dates of September 3, 2028 or September 9, 2028.
- Do not use affected catheters; contact Boston Scientific for replacement or credit.
- Return unused affected catheters to Boston Scientific.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1042-2026More Boston Scientific recalls
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