Z-1824-2024Class II

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

Name: Z-1824-2024 Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous...
Creator: LeMaitre Vascular, Inc.
Published: 2024-04-17
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2024-04-17 / Open, Classified

FDA source

LeMaitre Vascular, Inc. began a recall of Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies on 2024-04-17. FDA classified it as Class II and gives the reason as "The guide tip can become damaged and result in the tip detaching". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1824-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-17
Posted: 2024-05-15
Recalling firm: LeMaitre Vascular Inc.
Product: Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Product code: DXE Catheter, Embolectomy
Reason for recall: The guide tip can become damaged and result in the tip detaching.
FDA root cause: 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 [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.
Quantity in commerce: 5,604 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1824-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1824-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-15

Product code DXE

K910372Class IIIntimax Thrombectomy CatheterApplied Vascular Devices, Inc. / cleared 1991-04-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)