FDA Device recall Z-0390-2019
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, in…
- FDA Device
- Class II
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class II recall of Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, in… by Cordis, citing product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0390-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-05 |
| Published | 2018-11-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cordis |
| Distribution | US |
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
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
Identifiers
| code_info | Catalog Number Lot Number Expiry Date 4400322X 82144115 2020-04-30; 4400602S…Catalog Number Lot Number Expiry Date 4400322X 82144115 2020-04-30; 4400602S 82144141 2020-05-31; 4400515X 82144947 2020-06-30; 4400308S 82148810 2020-11-30; and 4400508S 82148811 2020-11-30. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0390-2019%22
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