Z-0204-2012

SUPER TORQUE MB Angiographic Catheter product is labeled in part: "5F (1.65 mm)110 cm .038" (0.97...

Name: Z-0204-2012 SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97...
Creator: Cordis Corporation
Published: 2011-11-21
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2011-11-21 / Terminated / root cause: labeling and UDI

FDA source

Cordis Corporation began a recall of SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open... on 2011-11-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0204-2012
Status: Terminated
Initiated: 2011-11-21
Posted: 2011-11-17
Terminated: 2013-07-23
Recalling firm: Cordis US Corp.
Product: SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic Catheter*** REF Cat No.***Lot***Use By***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 H739532598A3, Cat No 532-598A, No. MB 10, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H739532598B3, Cat No 532-598B, No. MB 20, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H73953298C3, Cat No 532-598C, No MB 20 French Size 5, Shape (PIG), Length, cm 65, Flow Rate, ml/sec, 30, Side Holes 6. UPN H73953298D3, Cat No 532-598D, No MB 2 French Size 5, Shape (PIG), Length , cm 70, Flow Rate, ml/sec, 30, Side Holes 10. 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.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 118,690 units
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico.
Product codes and lots: Not Lot Specific. Catalog No. 532-598A, 532-598B, 532-598C, and 532-598D.

Product code DQO

K992347Class IICordis Super Torque Mb Angiographic Catheter with Radiopaque Marker BandsCordis Corp. / cleared 1999-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)