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U.S. Department of Health and Human Services

Class 2 Device Recall Fogarty ThruLumen Embolectomy Catheter

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  Class 2 Device Recall Fogarty ThruLumen Embolectomy Catheter see related information
Date Initiated by Firm September 07, 2023
Date Posted November 06, 2023
Recall Status1 Open3, 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 2		 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 and Original Applicant = BAXTER HEALTHCARE CORP.
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