FDA Device recall Z-1538-2014
Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001
- FDA Device
- Class II
- terminated
- Published 2014-05-14
On 2014-05-14 the FDA classified a Class II recall of Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001 by Biorep Technologies, citing the support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1538-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-19 |
| Published | 2014-05-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biorep Technologies |
| Distribution | MN |
Product
Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
Reason
The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
Identifiers
| code_info | Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03). |
|---|
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-1538-2014%22
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