Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
This recall is currently active, issued November 6, 2023. It was issued by Edwards Lifesciences, Llc.
- Company
- Edwards Lifesciences, Llc
- Recall Initiated
- September 7, 2023
- Posted
- November 6, 2023
- Recall Number
- Z-0238-2024
- Quantity
- 185
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Distribution
OUS: Singapore, Taiwan, Canada
Lot / Code Info
UDI-DI: 00690103043532, Lot: 64936927
Root Cause
Nonconforming Material/Component
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.
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