Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
- Company
- Lemaitre Vascular, Inc.
- Recall Initiated
- April 17, 2024
- Posted
- May 15, 2024
- Recall Number
- Z-1824-2024
- Quantity
- 5,604 units
- Firm Location
- Burlington, MA
Reason for Recall
The guide tip can become damaged and result in the tip detaching.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.
Lot / Code Info
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.
Root Cause
Under Investigation by firm
Action Taken
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.