Z-2431-2021Class I

Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B

Name: Z-2431-2021 Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
Creator: Cordis Corporation
Published: 2021-07-21
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2021-07-21 / Terminated / root cause: design

FDA source

Cordis Corporation began a recall of Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B on 2021-07-21. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2431-2021
Classification: Class I
Status: Terminated
Initiated: 2021-07-21
Posted: 2021-09-15
Terminated: 2024-09-09
Recalling firm: Cordis US Corp.
Product: Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: 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 tag: design
FDA 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 in commerce: 71330 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
Product codes and lots: all codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2431-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2428-2021	Class I	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-15
Z-2429-2021	Class I	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-15
Z-2430-2021	Class I	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-15
Z-2431-2021	Class I	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-15
Z-2432-2021	Class I	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-15

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)