Fogarty Thru-Lumen Embolectomy Catheter — Class II medical device recall Z-0238-2024
Ongoing recall by Edwards Lifesciences, LLC, reported 2023-11-15. Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater
| Recall number | Z-0238-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2023-09-07 |
| Classified | 2023-11-06 |
| Reported by FDA | 2023-11-15 |
| Countries outside the US | CA, SG, TW |
| Quantity | 185 |
| UPC / GTIN / UDI-DI | 00690103043532 |
| Lot numbers | 64936927 |
| Model numbers | 12TLW805F35 |
Product
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Reason for recall
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
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-0238-2024. 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.