FDA Device recall Z-0135-2014
Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic…
- FDA Device
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic… by Edwards Lifesciences, citing edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product ev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0135-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-26 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
Product
Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6Fr to 18Fr can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Reason
Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.
Identifiers
| code_info | Lot number 59261626 expiry 06/01/15 |
|---|
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-0135-2014%22
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