FDA Medical Device Recalls (openFDA)
Cordis Corporation: SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***MULTIPURPOSE A SUPER TORQUE MB***Max. 1200 psi (8274 kPa)***Markers***OPEN end***Sideholes***SPECIAL***Angiographic Catheter*** REF Cat No.***Lot***Use By***Sterile EO***Assembled in Mexico Cordis Corporation, 14201 NW 60th Ave. Miami Lakes, Florida 33014, USA***EC***REP*** Cordis Cashel, Cahir Road Cashel, Co Tipperary, Ireland***Cordis***a Johnson&Johnson company***" UPN SRD5724MB, No MB 2, Length, cm 100, Sideholes 2. UPN SRD5727MB, No MB 4, Length, cm 80, Sideholes 4. Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.
- Recall number
- Z-0205-2012
- Recalling firm
- Cordis Corporation
- Product
- SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***MULTIPURPOSE A SUPER TORQUE MB***Max. 1200 psi (8274 kPa)***Markers***OPEN end***Sideholes***SPECIAL***Angiographic Catheter*** REF Cat No.***Lot***Use By***Sterile EO***Assembled in Mexico Cordis Corporation, 14201 NW 60th Ave. Miami Lakes, Florida 33014, USA***EC***REP*** Cordis Cashel, Cahir Road Cashel, Co Tipperary, Ireland***Cordis***a Johnson&Johnson company***" UPN SRD5724MB, No MB 2, Length, cm 100, Sideholes 2. UPN SRD5727MB, No MB 4, Length, cm 80, Sideholes 4. Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.
- Status
- Terminated
- Initiated
- 2011-11-21
- Posted
- 2011-11-17
- Terminated
- 2013-07-23
- Reason
- Cordis Corporation is issuing a Correction for their SUPER TORQUE MB Angiographic Catheter after receiving a report of marker bands dislodged during a procedure. Model Numbers 532598A, 532598B, 532598C, 532598D, SRD5724MB and SRD5727MB are affected by the Cordis Correction.
- Root cause
- Error in labeling
- Action
- Cordis Corporation sent a Correction letter dated November 21, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers are instructed to read the "Description" and "Recommendations" sections, sign and return an enclosed Acknowledgement Form, and to maintain awareness of the communication until the information has been incorporated into the Cordis Super Torque MB Catheter labeling. Contact Cordis at 800-781-0282 for questions regarding this notice.
- Quantity
- 310 units
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico.
- Lot, serial or model codes
- Not Lot Specific. Catalog No. SRD5724MB and SRD5727MB.
- 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