Recall Z-0238-2024 ยท DXE Catheter, Embolectomy
Edwards Lifesciences, LLC
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
| Date | Nov 6, 2023 (initiated Sep 7, 2023) |
| Status | Open, Classified |
| Reason | Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds). |
| Root cause | Nonconforming Material/Component |
| Action | On 9/7/23, correction notices were sent to customers informing them to take the following actions: 2) Return affected devices. 3) Forward notice to any of your customers who have purchased the impacted devices. 3) Complete and return the acknowledgement form. |
| Quantity | 185 |
| Distribution | OUS: Singapore, Taiwan, Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K892410 | FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER Baxter Healthcare Corp, Jul 20, 1989 |