Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Reported: November 15, 2023 Initiated: September 7, 2023 #Z-0238-2024
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).
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 185
- Distribution
- OUS: Singapore, Taiwan, Canada
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35. Recalled by Edwards Lifesciences, LLC. Units affected: 185.
Why was this product recalled? ▼
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2023. Severity: Moderate. Recall number: Z-0238-2024.
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