Edwards Lifesciences, LLC Recall 93172
Description: Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Edwards Lifesciences, LLC Recall 93172 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0238-2024 |
| Event ID | 93172 |
| Event Description | Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 |
| Product Type | Devices |
| Distribution | OUS: Singapore, Taiwan, Canada |
| Quantity | 185 |
| Recall Reason | Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds). |
| Device Classification | 20231115 |
| Device Code Info | UDI-DI: 00690103043532, Lot: 64936927 |
| Center Classification Date | 20231106 |
| Recall Initiation Date | 20230907 |
| Recalling Firm | Edwards Lifesciences, LLC |
| Initial Notification | Letter |
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