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
Recall
- Recall Number
- Z-1042-2026
- Event Number
- 98149
- Firm
- Boston Scientific Corporation
- FEI Number
- 3002095335
- Product Code
- LIT
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- December 3, 2025
- Posted
- January 9, 2026
- Address
- 1 Scimed Pl, Maple Grove, MN, 55311-1565
Description
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
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 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 visible location near the affected devices to ensure it is readily accessible to all handlers and users of the device. 3. Forward this notice to any healthcare professional from your organization and to any facilities where affected devices have been transferred, including hospitals or sites within your network. If you are a distributor, this notice must be forwarded to your customers to ensure notification of this device removal is carried out to the end-user level. 4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions on page four. 5. Return affected devices." For questions regarding this communication, please contact your local Boston Scientific representative.
US Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX, FL, IL.
21 units