Class 2 Device Recall Fogarty ThruLumen Embolectomy Catheter

• Date Initiated by Firm: September 07, 2023
• Date Posted: November 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0238-2024
• Recall Event ID: 93172
• 510(K)Number: K892410
• Product Classification: Catheter, embolectomy - Product Code DXE
• Product: Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
• Code Information: UDI-DI: 00690103043532, Lot: 64936927
• Recalling Firm/ Manufacturer: Edwards Lifesciences, LLC; 1 Edwards Way; Irvine CA 92614-5688
• For Additional Information Contact: Linnette Torres; 949-756-4582
• Manufacturer Reason for Recall: Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
• FDA Determined Cause: Nonconforming Material/Component
• 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.
• Quantity in Commerce: 185
• Distribution: OUS: Singapore, Taiwan, Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DXE