CLASS II Device recall · Reported 18 Mar 2020 · FDA Enforcement Report
Powerflex P3, PTA Dilation Catheter recalled by Cordis
Cordis is recalling Cordis Powerflex P3, PTA Dilation Catheter. The recall was initiated on 8 Jan 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1477-2020
- FDA event ID
- 84680
- Recalling firm
- Cordis, Miami Lakes, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jan 2020
- FDA classified
- 12 Mar 2020
- Reported
- 18 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 8 Jan 2020 | Recall initiated by company | |
| 12 Mar 2020 | Classified by FDA | +64 days |
| 18 Mar 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Where it was distributed
US and UK
Questions about this recall
Is Powerflex P3, PTA Dilation Catheter recalled?
Yes. Cordis recalled Powerflex P3, PTA Dilation Catheter on 8 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1477-2020.
Why was it recalled?
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.
Which lots are affected?
Lot 82155955, Use by date 2021-06-30
Where was it sold?
US and UK
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |