LeMaitre Vascular AnastoClip GC Vessel Closure System-Large… recallZ-0165-2011 · Lemaitre Vascular, Inc. · initiated Sep 22, 2010
Terminated All recalls posted in October 2010
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
Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and Large sizes incorrectly identified the size of the clip as XL, while the device inside was either a Medium or Large size.
FDA root cause category: Packaging change control
What the company is doing
LeMaitre Vascular issued an Urgent AnastoClip GC Device Field Safety Notice letter dated Sepember 28, 2010 identifying the affected devices and actions to be taken by customers. The letter contains a form that is requested to be returned to LeMaitre Vascular as record of notification and reconciliation. The letter provides an option for the notified hospital to return the affected product for replacement if unused or if they simply wish to have it corrected. Customers can contact LeMaitre Customer Service for replacement at 800 628-9470.
Recall details
- Recall number
- Z-0165-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 22, 2010
- Posted by the FDA
- Oct 28, 2010
- Recalling firm
- Lemaitre Vascular, Inc.
- Quantity
- 108 units
- Product code
- HBT
- FDA submissions
- K091987
- Distribution
- Nationwide Distribution: to the states of CA, FL, GA, IL, IN, LA, MD, MS, NJ, OK, OR, and TX.
Product description
LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size Models: 4007-03 Large size 3 Pack 4008-03 Large size 10 Pack 4007-07 Large size 1 Pack Manufactured by LeMatire Vascular Inc, Burlington, MA 01803
Code information (models, lots, serial numbers)
Lot Number Expiration Date AGC1015 2012-10 AGC1016 2012-10 AGC1017 2012-10 AGC1018 2012-11 AGC1019 2012-11 AGC1022 2012-11 AGC1023 2012-11 AGC1024 2012-12 AGC1025 2013-01 AGC1027 2013-01 AGC1028 2013-01
Other devices under the same FDA submission
2 devices cleared under K091987 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AnastoClip GC 8cm (Medium) 4008-06Lemaitre Vascular, Inc. · Clip, Implantable7 reports
- AnastoClip GC 8cm (Large) 4008-07Lemaitre Vascular, Inc. · Clip, Implantable1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 56908).
- Z-0164-2011 · TerminatedLeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size Models: 4007-02 Medium size 3 Pack 4008-02 Medium size 10 Pack 4007-06 Medium size 1 Pack Manufactured by LeMatire…
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 18, 2026. Text above is shown as published by the FDA.
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