Edwards Lifesciences Duraflo coated Femoral Cannula — Class II medical device recall Z-1111-2013
Terminated recall by Edwards Lifesciences, LLC, reported 2013-04-24, distributed nationwide. Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may
| Recall number | Z-1111-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2013-03-14 |
| Classified | 2013-04-14 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2016-03-08 |
| Distributed | Nationwide (US) |
| Quantity | 379 units |
| Reason classes | sterility |
| Lot numbers | 59337174 |
| Model numbers | DIIFEMII018A |
Product
Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.
Reason for recall
Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1111-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.