Syntel Silicone Thrombectomy Catheter recallZ-1824-2024 · LeMaitre Vascular, Inc. · initiated Apr 17, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from LeMaitre Vascular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The guide tip can become damaged and result in the tip detaching.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected], 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 [email protected] from Monday through Friday, 8:00 AM to 4:30 PM EST.
Recall details
- Recall number
- Z-1824-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 17, 2024
- Posted by the FDA
- May 15, 2024
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 5,604 units
- Product code
- DXE
- FDA submissions
- K910372
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.
Product description
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- Syntel Silicone Thrombectomy Catheter A4545Lemaitre Vascular, Inc. · Catheter, Embolectomy1 recall6 reports
- Syntel Silicone Thrombectomy Catheter A4548Lemaitre Vascular, Inc. · Catheter, Embolectomy1 recall0 reports
- Syntel Silicone Thrombectomy Catheter A4554Lemaitre Vascular, Inc. · Catheter, Embolectomy1 recall0 reports
- Syntel Silicone Thrombectomy Catheter A4558Lemaitre Vascular, Inc. · Catheter, Embolectomy1 recall0 reports
- Syntel Silicone Thrombectomy Catheter A4568Lemaitre Vascular, Inc. · Catheter, Embolectomy1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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