Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
FDA Recall Z-0238-2024 · Posted 2023-11-06
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Recalling FirmEdwards Lifesciences, LLC
Recall StatusOpen, Classified
Product CodeDXE
Date Initiated2023-09-07
Product Quantity185
Reason for Recall
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
OUS: Singapore, Taiwan, Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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