FDA Enforcement
Class II
Ongoing
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Recall: Z-0238-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0238-2024
- Event ID
- 93172
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Edwards Lifesciences, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2023
- Initiation Date
- September 7, 2023
- Classification Date
- November 6, 2023
- Address
- 1 Edwards Way, Irvine, CA, 92614-5688, United States
Description
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Reason
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Code Info
UDI-DI: 00690103043532, Lot: 64936927
Distribution
OUS: Singapore, Taiwan, Canada
Quantity
185