CLASS II ONGOING Device recall · Reported 22 May 2024 · FDA Enforcement Report

Syntel Silicone Thrombectomy Catheter, Sterile recalled

LeMaitre Vascular is recalling Syntel Silicone Thrombectomy Catheter, Sterile, distributed nationwide in the US. The recall was initiated on 17 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem 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 recalled5,604 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1824-2024
FDA event ID: 94457
Recalling firm: LeMaitre Vascular, Burlington, MA
Classification: Class II
Status: Ongoing
Recall initiated: 17 Apr 2024
FDA classified: 15 May 2024
Reported: 22 May 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

17 Apr 2024	Recall initiated by company
15 May 2024	Classified by FDA	+28 days
22 May 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from LeMaitre Vascular

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Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Device	CLASS II	Artegraft Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Packaging Defects	Nationwide
29 Oct 2025Device	CLASS II	Artegraft¿ Collagen Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Packaging Defects	AR
15 Oct 2025Device	CLASS II	Artegraft Collagen Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Labeling Errors	NJ
8 Oct 2025Device	CLASS II	Artegraft Collagen Vascular Grafts recalled by LeMaitre Vascular	LeMaitre Vascular	Other	Nationwide
21 May 2025Device	CLASS II	Pruitt Irrigation Occlusion Catheter recalled by LeMaitre Vascular	LeMaitre Vascular	Sterility	Nationwide

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