FDA Device recall Z-0380-2016
LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48
- FDA Device
- Class II
- terminated
- Published 2015-12-16
On 2015-12-16 the FDA classified a Class II recall of LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48 by Lemaitre Vascular, citing manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0380-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-21 |
| Published | 2015-12-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Lemaitre Vascular |
| Distribution | US |
Product
LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
Reason
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Identifiers
| code_info | Lot Numbers: OTW3092¿OTW3084 OTW3084 (sample) OTW3087¿OTW3101¿ |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0380-2016%22
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