Recall Z-1042-2026 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Boston Scientific Corporation
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
| Date | Jan 9, 2026 (initiated Dec 3, 2025) |
| Status | Open, Classified |
| Reason | 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 r |
| Root cause | Process change control |
| Action | Boston Scientific issued an Urgent Medical Device Removal notice to its consignees on 12/3/2025 by letter delivered via a courier service. The notice explained the issue, clinical impact to the patient, and requested the following actions: "Instructions: 1. Further distribution or use of any remaining devices (Attachment 1) affected by this removal should cease immediately. Do NOT use affected devices and remove those devices from your facility s inventory. Segregate the units in a secure place until they can be returned to Boston Scientific. 2. Immediately post this information in a visibl |
| Quantity | 21 units |
| Distribution | US Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX, FL, IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111295 | .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS Boston Scientific Corporation, May 31, 2011 |