Boston Scientific recalls specific batches of Coyote Over-the-Wire PTA Balloon Dilation Catheters due to potential inflation/deflation difficulties during peripheral vascular procedures. Affected units were manufactured between September 12 and October 13, 2025.
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.
Boston Scientific is recalling certain batches of Coyote Over-the-Wire PTA Balloon Dilation Catheters that may not inflate or deflate properly during use in peripheral blood vessels. This could lead to complications during medical procedures if the catheter fails to function correctly.
The catheters may not inflate or deflate properly due to a manufacturing process variation. This could cause issues during medical procedures where precise control of the catheter's size is needed in peripheral blood vessels.
Healthcare professionals using these catheters for peripheral vascular procedures are most at risk. Patients undergoing such procedures with affected catheters could experience complications if the device fails during use.
Check for the model numbers REF H74939186251210 (2.5mm x120mm) or REF H74939186351210 (3.5mm x120mm). Affected units were manufactured between September 12 and October 13, 2025, with specific batch numbers and expiration dates.
Identify the model number and batch date from the product label to confirm if it is affected.
The recall is for specific batches that may have manufacturing issues; unaffected units are safe. Boston Scientific has addressed the issue in other batches.
Check the model number on the catheter: REF H74939186251210 or REF H74939186351210, and verify the manufacturing date was between September 12 and October 13, 2025.
Contact Boston Scientific directly to confirm if your catheter is affected and follow their instructions for replacement or return.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1042-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1042-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
