Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
FDA device recall Z-0238-2024 · posted 2023-11-06 · Open, Classified
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- DXE
- Quantity affected
- 185
- Distribution
- OUS: Singapore, Taiwan, Canada
- Date initiated
- 2023-09-07
- Date posted
- 2023-11-06
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER (K892410) | Baxter Healthcare Corp | 1989-07-20 |