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Recall Observatory FDA recall evidence

Device product

Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.

Z-1824-2024

April 17, 2024

Class II

Product summary

Firm
LeMaitre Vascular, Inc.
Event
Event 94457
Status
Ongoing
Classification
Class II
Quantity
5,604 units
Official record key
device-enforcement:Z-1824-2024

Official wording

Reason: The guide tip can become damaged and result in the tip detaching.

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.

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The guide tip can become damaged and result in the tip detaching.