Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate… — Class II medical device recall Z-0998-2015
Terminated recall by Cordis Corporation, reported 2015-01-28, distributed nationwide. One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilize
| Recall number | Z-0998-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2014-12-22 |
| Classified | 2015-01-16 |
| Reported by FDA | 2015-01-28 |
| Terminated | 2015-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 120 |
| Lot numbers | 15617883 |
| Model numbers | 4400615X |
Product
Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post- dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Reason for recall
One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
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-0998-2015. 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.