CLASS II Device recall · Reported 19 Sep 2018 · FDA Enforcement Report
AnastoClip GC Closure System recalled by LeMaitre Vascular
LeMaitre Vascular is recalling AnastoClip GC Closure System, distributed in Florida, Nevada, Oklahoma, South Carolina, Texas. The recall was initiated on 19 Jun 2018 and the FDA has classified it as Class II.
Check your package
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-3042-2018
- FDA event ID
- 80627
- Recalling firm
- LeMaitre Vascular, Burlington, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jun 2018
- FDA classified
- 13 Sep 2018
- Reported
- 19 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Jun 2018 | Recall initiated by company | |
| 13 Sep 2018 | Classified by FDA | +86 days |
| 19 Sep 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.
Product as listed by the FDA
AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.
Where it was distributed
Distributed to accounts in FL, NV, OK, SC, and TX.
Questions about this recall
Why was it recalled?
The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.
Which lots are affected?
AGC2134
Where was it sold?
Distributed to accounts in FL, NV, OK, SC, and TX.
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
All 70| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artegraft Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Packaging Defects | Nationwide |
| Device | CLASS II | Artegraft¿ Collagen Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Packaging Defects | AR |
| Device | CLASS II | Artegraft Collagen Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Labeling Errors | NJ |
| Device | CLASS II | Artegraft Collagen Vascular Grafts recalled by LeMaitre Vascular | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Pruitt Irrigation Occlusion Catheter recalled by LeMaitre Vascular | LeMaitre Vascular | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |