Edwards EndoReturn Arterial Cannula — Class II medical device recall Z-1972-2013
Terminated recall by Edwards Lifesciences, LLC, reported 2013-08-21, distributed nationwide. Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an inco
| Recall number | Z-1972-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2013-07-16 |
| Classified | 2013-08-14 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2016-11-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 855 |
| Reason classes | device malfunction |
| Lot numbers | 59464327, 59484349, 59484350, 59484351, 59496984, 59512146, 59513272, 59516933, 59516936, 59516940, 59531385, 59531386, 59534430, 59535739, 59541763, 59543708 |
| Model numbers | 59464327, 59484349, 59484350, 59484351, 59496984, 59512146, 59513272, 59516933, 59516936, 59516940, 59531385, 59531386, 59534430, 59535739, 59541763, 59543708, ER21B, ER23B |
Product
Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced cannula with hemostasis valve, an introducer, and a guidewire. The cannulae have a wire reinforced section to provide kink resistance and flexibility, tapered tips to aid in insertion and advancement into the femoral artery, a non-reinforced clamp site, a 3/8 in. (9.5 mm) barbed connector, and a hemostasis valve (available on some versions) that allows passage of catheters, such as the EndoClamp aortic catheter. The introducers accept a .038 in. (0.97 mm) guidewire and are marked to simplify assembly and indicate alignment. On some versions, a connector hub secures and immobilizes the introducer within the cannula for easier, one person insertion of the cannula/introducer assembly.
Reason for recall
Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion device.
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-1972-2013. 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.