Syntel Silicone Thrombectomy Catheter recalled due to guide tip detachment risk
LeMaitre Vascular is recalling 5,604 units of Syntel Silicone Thrombectomy Catheters worldwide because the guide tip can become damaged and detach during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a risk-of-harm medical device where no illnesses or injuries have been reported. The guide tip detachment poses potential for serious patient injury during thrombectomy procedures, meeting the criteria for Score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
LeMaitre Vascular, Inc. is recalling 5,604 units of Syntel Silicone Thrombectomy Catheters worldwide. These sterile, prescription-only medical devices are used in vascular grafts and peripheral venous thrombectomies. The guide tip can become damaged and detach during use.
The recalled devices are distributed in the United States, Australia, Canada, and Spain. Multiple lot numbers are affected, ranging from SST1004 to SST1071.
The recalled product
- Product
- Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
- Manufacturer
- LeMaitre Vascular, Inc.
- Hazard
- Affected units
- 5,604
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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