Class II — Edwards Lifesciences, LLC
| Recalling firm | Edwards Lifesciences LLC |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds). |
| Product | Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 |
| Quantity | 185 |
| Distribution | OUS: Singapore, Taiwan, Canada |
| Initiated | 2023-09-07 |
| Classified | 2023-11-06 |
| Recall number | Z-0238-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Edwards Lifesciences, LLC (Z-0238-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93172/
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