FDA Device recall Z-2756-2016
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6)
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6) by Sorin Group Usa, citing sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at ei….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2756-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-12 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sorin Group Usa |
| Distribution | IL, MO, TX |
Product
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect. The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip
Reason
Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.
Identifiers
| code_info | Lot Numbers: 1526500032, 1529300026, 1602600042. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2756-2016%22
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