Z-0238-2024 Class II Ongoing
FDA device recall Z-0238-2024 was initiated by Edwards Lifesciences, LLC on September 7, 2023 and is designated Class II. Reason for recall: Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds). The recall status is ongoing. Affected quantity: 185.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2023
- Initiation Date
- September 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 185
Product Description
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Reason for Recall
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Distribution Pattern
OUS: Singapore, Taiwan, Canada
Code Information
UDI-DI: 00690103043532, Lot: 64936927