Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S recallZ-1477-2020 · Cordis Corporation · initiated Jan 8, 2020
Class II Terminated All recalls posted in February 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cordis Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Pending
What the company is doing
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: [email protected].
Recall details
- Recall number
- Z-1477-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 8, 2020
- Posted by the FDA
- Feb 28, 2020
- Recalling firm
- Cordis Corporation
- Quantity
- 89 units
- Product code
- LIT
- FDA submissions
- K032737
- Distribution
- US and UK
Product description
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Code information (models, lots, serial numbers)
Lot 82155955, Use by date 2021-06-30
Other devices under the same FDA submission
25 devices cleared under K032737 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- POWERFLEX 4156040SCordis US Corp. · CATHETER, PERCUTANEOUS45 reports
- POWERFLEX 4155040SCordis Corporation · CATHETER, PERCUTANEOUS21 reports
- POWERFLEX 4157040SCordis Corporation · CATHETER, PERCUTANEOUS14 reports
- POWERFLEX 4158040SCordis US Corp. · CATHETER, PERCUTANEOUS13 reports
- POWERFLEX 4204040TCordis US Corp. · CATHETER, PERCUTANEOUS9 reports
- POWERFLEX 4206040SCordis US Corp. · CATHETER, PERCUTANEOUS9 reports
- POWERFLEX 4202040SCordis US Corp. · CATHETER, PERCUTANEOUS8 reports
- POWERFLEX 4205040TCordis Corporation · CATHETER, PERCUTANEOUS6 reports
- POWERFLEX 4158060SCordis Corporation · CATHETER, PERCUTANEOUS5 reports
- POWERFLEX 4150060SCordis Corporation · CATHETER, PERCUTANEOUS4 reports
- POWERFLEX 4159040SCordis Corporation · CATHETER, PERCUTANEOUS3 reports
- POWERFLEX 4156040TCordis US Corp. · CATHETER, PERCUTANEOUS2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page