FDA Medical Device Recalls (openFDA)
Cordis Corporation: Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
- Recall number
- Z-2428-2021
- Recalling firm
- Cordis Corporation
- Product
- Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
- Status
- Terminated
- Initiated
- 2021-07-21
- Posted
- 2021-09-15
- Terminated
- 2024-09-09
- Reason
- Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.
- Root cause
- Device Design
- Action
- The firm disseminated an Urgent Medical Device Field Correction notice beginning on 07/21/2021. The letter described the problem and provided recommendations for clinical use found in the instructions for use.
- Quantity
- 45 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
- Lot, serial or model codes
- All codes
- 510(k) numbers
- ["K992347"]
- PMA numbers
- not on file
- Product code
- DQO
- 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