FDA Device recall Z-0998-2015
Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and re…
- FDA Device
- Class II
- terminated
- Published 2015-01-28
On 2015-01-28 the FDA classified a Class II recall of Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and re… by Cordis, citing one unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0998-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-22 |
| Published | 2015-01-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cordis |
| Distribution | US |
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
One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
Identifiers
| code_info | Catalog 4400615X, demo lot 15617883 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0998-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.