FDA Medical Device Recalls (openFDA)
Cordis Corporation: Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
- Recall number
- Z-2235-2021
- Recalling firm
- Cordis Corporation
- Product
- Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
- Status
- Terminated
- Initiated
- 2021-07-19
- Posted
- not on file
- Terminated
- 2023-02-16
- Reason
- The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
- Root cause
- Under Investigation by firm
- Action
- The firm initiated the recall by letter on 07/19/2021. The letter explained the issue and requested the return of the devices.
- Quantity
- 8 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
- Lot, serial or model codes
- Lot/Batch number 82219442
- 510(k) numbers
- ["K133843"]
- 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