Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter — Class II medical device recall Z-1042-2026
Ongoing recall by Boston Scientific Corporation, reported 2026-01-21, distributed nationwide. Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Tra
| Recall number | Z-1042-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2025-12-03 |
| Classified | 2026-01-09 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 21 units |
| UPC / GTIN / UDI-DI | 08714729796527, 08714729796756 |
| Lot numbers | 37370117, 37416646 |
| Model numbers | H74939186251210, H74939186351210 |
| Expiration dates | 2028-09-03, 2028-09-09 |
Product
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1042-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.