Rotarex Atherectomy System and Instructions for Use — Class I medical device recall Z-1244-2025
Ongoing recall by Bard Peripheral Vascular Inc, reported 2025-03-12, distributed nationwide. Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood
| Recall number | Z-1244-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2025-02-05 |
| Classified | 2025-03-05 |
| Reported by FDA | 2025-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 15,755 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07640142811855, 07640142811862, 07640142811879, 07640142811886 |
| Model numbers | 80236, 80237, 80238, 80239 |
Product
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
Reason for recall
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.
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-1244-2025. 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.