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U.S. Department of Health and Human Services

Class 2 Device Recall Syntel Silicone Thrombectomy Catheter

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  Class 2 Device Recall Syntel Silicone Thrombectomy Catheter see related information
Date Initiated by Firm April 17, 2024
Date Posted May 15, 2024
Recall Status1 Open3, Classified
Recall Number Z-1824-2024
Recall Event ID 94457
510(K)Number K910372  
Product Classification Catheter, embolectomy - Product Code DXE
Product Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Code Information Item No. A4545, A4548, A4554, A4558, A4568; GTIN: 840663109807, 840663109838, 840663109814, 840663109821, 840663109845; Lot No: SST1004, SST1005, SST1006, SST1007, SST1009, SST1010, SST1013, SST1018, SST1019, SST1020, SST1021, SST1022, SST1023, SST1024, SST1025, SST1026, SST1027, SST1028, SST1029, SST1030, SST1031, SST1032, SST1033, SST1034, SST1035, SST1036, SST1037, SST1038, SST1041, SST1042, SST1043, SST1044, SST1045, SST1046, SST1047, SST1048, SST1049, SST1050, SST1051, SST1054, SST1055, SST1056, SST1057, SST1058, SST1059, SST1060, SST1061, SST1062, SST1063, SST1064, SST1065, SST1066, SST1067, SST1068, SST1071.
Recalling Firm/
Manufacturer		 LeMaitre Vascular, Inc.
32 3rd Ave
Burlington MA 01803-4414
For Additional Information Contact David Hissong
781-425-1670
Manufacturer Reason
for Recall		 The guide tip can become damaged and result in the tip detaching.
FDA Determined
Cause 2		 Under Investigation by firm
Action Consignees were mailed an URGENT MEDICAL DEVICE RECALL Notification, dated 4/10/2024. The notification instructs consignees to inspect their inventory for and quarantine affected devices, complete and return the provided Response Form to recalls@lamaitre.com, and return affected devices for credit. If product was further distributed, the recall notification is to be forwarded for customer awareness. Consignees with any questions are to contact Rose Lerer at rlerer@lemaitre.com from Monday through Friday, 8:00 AM to 4:30 PM EST.
Quantity in Commerce 5,604 units
Distribution Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.
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 = APPLIED VASCULAR DEVICES, INC.
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