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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Surgical Equipment

LeMaitre Vascular, Inc.: Syntel Silicone Thrombectomy Catheter Recalled for Detaching Guide Tip

Agency Publication Date: May 15, 2024
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Summary

LeMaitre Vascular, Inc. has recalled 5,604 units of the Syntel Silicone Thrombectomy Catheter used in surgical procedures to remove blood clots from veins and grafts. The recall was initiated because the guide tip on the catheter can become damaged and detach from the device. This issue was identified across various item numbers and specific manufacturing lots distributed nationwide in the United States and internationally.

Risk

If the guide tip detaches while inside a patient's body, it can remain in the vascular system, potentially causing blockages, internal injury, or necessitating additional surgical procedures to retrieve the fragment.

What You Should Do

  1. Check your medical inventory for Syntel Silicone Thrombectomy Catheters with Item Numbers A4545, A4548, A4554, A4558, or A4568.
  2. Verify the GTIN (Global Trade Item Number) on the packaging: 840663109807, 840663109838, 840663109814, 840663109821, or 840663109845.
  3. Confirm the lot number matches any of the following: 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, or SST1071.
  4. Stop using affected catheters immediately and set them aside to prevent accidental use in clinical settings.
  5. Contact LeMaitre Vascular, Inc. for specific instructions regarding the return or disposal of the affected devices and to discuss potential replacements or refunds.
  6. Healthcare providers should contact the manufacturer or their medical supervisor for further guidance on patient safety and alternative devices.
  7. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification by letter for device defect.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Syntel Silicone Thrombectomy Catheter
Model / REF:
A4545
A4548
A4554
A4558
A4568
UPC Codes:
840663109807
840663109838
840663109814
840663109821
840663109845
Lot Numbers (55):
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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94457
Status: Active
Manufacturer: LeMaitre Vascular, Inc.
Sold By: Hospitals; Surgical Centers; Medical Distributers
Manufactured In: United States
Units Affected: 5,604 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.