Cordis POWERFLEX PRO PTA Dilatation Catheter — Class II medical device recall Z-0390-2019
Terminated recall by Cordis Corporation, reported 2018-11-14, distributed nationwide. Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the
| Recall number | Z-0390-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2018-09-05 |
| Classified | 2018-11-06 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2021-02-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, NL |
| Reason classes | potency |
| Lot numbers | 4400308S, 4400322X, 4400508S, 4400515X, 4400602S, 82144115, 82144141, 82144947, 82148810, 82148811 |
| Model numbers | 4400308S, 4400322X, 4400508S, 4400515X, 4400602S, 82144115, 82144141, 82144947, 82148810, 82148811 |
Product
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is 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 postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Reason for recall
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
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-0390-2019. 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.