AORTIC ARCH CANNULA — Class II medical device recall Z-2147-2016
Terminated recall by Sorin Group USA, Inc., reported 2016-07-20, distributed nationwide. Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end ma
| Recall number | Z-2147-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group USA, Inc., Arvada, CO, United States |
| Recall initiated | 2016-06-22 |
| Classified | 2016-07-08 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2017-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, IT |
| Quantity | 5,740 |
| Lot numbers | 1505600017, 1505600018, 1506500005, 1509200078, 1513100112, 1513900027, 1513900028, 1514700045, 1516600192, 1516800126, 1517800004, 1519500037, 1520100049, 1520100050, 1520900031, 1520900033, 1521600126, 1523000093, 1523600120, 1525100023, 1525800026, 1526500032, 1526500033, 1526500034, 1526500072, 1527200050, 1527200051, 1527200052, 1527800163, 1529300026, 1529300027, 1529300028, 1533500033, 1534200034, 1601900027, 1601900028 |
| Model numbers | NA-55X7, NA-55X8 |
Product
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) 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.
Reason for recall
Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.
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-2147-2016. 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.