FDA Medical Device Recalls (openFDA)
Cordis Corporation: Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
- Recall number
- Z-1477-2020
- Recalling firm
- Cordis Corporation
- Product
- Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
- Status
- Terminated
- Initiated
- 2020-01-08
- Posted
- 2020-02-28
- Terminated
- 2023-01-13
- 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.
- Root cause
- Pending
- Action
- The firm initiated the recall by letter on 01/08/2020. The letter explained the issue and the hazard, and requested the consignee check their inventory for the product, isolate any affected units and return the acknowledgement form. The firm is seeking the return of the affected units. The firm directed the consignee to share the notice with any entity to whom the product was further distributed. Questions regarding the recall should be sent to: GMB-FieldCorrectiveAction@cardinalhealth.com.
- Quantity
- 89 units
- Distribution
- US and UK
- Lot, serial or model codes
- Lot 82155955, Use by date 2021-06-30
- 510(k) numbers
- ["K032737"]
- PMA numbers
- not on file
- Product code
- LIT
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28