Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Summary
The FDA issued a Class II for Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts by LeMaitre Vascular, Inc.. Reason: The guide tip can become damaged and result in the tip detaching..
Details
Source
Device Recall
External ID
Z-1824-2024
Action Date
2024-05-22
Status
Ongoing
Category
device
Product Description
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
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.
Quantity Affected: 5,604 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-17
Company
Burlington, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
LeMaitre Vascular, Inc. has 11 FDA actions in our database, including 10 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LeMaitre Vascular, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LeMaitre Vascular, Inc. have FDA actions?
LeMaitre Vascular, Inc. has 11 FDA actions in our database, including 10 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1824-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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