FDAFDA · Food and drugs·Recall number Z-0238-2024
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Published November 15, 2023 · Recall initiated: September 7, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Edwards Lifesciences, LLC
- Distributor
- OUS: Singapore, Taiwan, Canada
- Lot
- UDI-DI: 00690103043532, Lot: 64936927
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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