Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The… — Class II medical device recall Z-1385-2018
Terminated recall by Datascope Corporation, reported 2018-04-25, distributed nationwide. The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindicatio
| Recall number | Z-1385-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corporation, Fairfield, NJ, United States |
| Recall initiated | 2018-02-21 |
| Classified | 2018-04-16 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2020-03-18 |
| Distributed | Nationwide (US) |
| Quantity | 12,744 |
Product
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Reason for recall
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
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-1385-2018. 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.