FDA Medical Device Recalls (openFDA)
Cordis Corporation: Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
- Recall number
- Z-0250-2020
- Recalling firm
- Cordis Corporation
- Product
- Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
- Status
- Terminated
- Initiated
- 2019-10-04
- Posted
- not on file
- Terminated
- 2020-12-14
- Reason
- Product was manufactured utilizing an expired inner body.
- Root cause
- Process control
- Action
- Cordis notified customers on about 10/04/2019, via Urgent MEDICAL DEVICE RECALL letter delivered by sales representatives. Customers were informed that the Cordis MAXI LD" PTA Dilatation Catheter was manufactured utilizing an expired inner body. For an expired inner body, a degradation of material may contribute to a collapse of the guidewire lumen resulting in a resistance during insertion or backloading of the guidewire into the lumen. Instructions included to read the recall letter, immediately check inventory to conform if the affected product is in your possession, identify and set aside any units from the affected lot, complete and return the provided Acknowledgement Form directly to Cordis via fax (614-495-5571) or email to GMB-FieldCorrectiveAction@cardinalhealth.com. Customers were also instructed to arrange for return of affected product, provide the recall letter to personnel at your facility who need to be made aware and any other facility that may have been sent the affected units.
- Quantity
- 21 units
- Distribution
- US distribution to AL, AZ, FL, MN, and MO
- Lot, serial or model codes
- Catalog Number: 4171460S; Lot Number: 82169860; Expiry Date: 10/31/2020
- 510(k) numbers
- ["K991811"]
- 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