FDA Device recall Z-1477-2020
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
- FDA Device
- Class II
- terminated
- Published 2020-03-18
On 2020-03-18 the FDA classified a Class II recall of Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S by Cordis, citing cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1477-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-08 |
| Published | 2020-03-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cordis |
| Distribution | n/a |
Product
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Reason
Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.
Identifiers
| code_info | Lot 82155955, Use by date 2021-06-30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1477-2020%22
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