Food, drugs, devices › Cordis Corporation
Device recall: Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
FDA enforcement event 88372 is a device recall by Cordis Corporation of Miami Lakes, FL, initiated 21 Jul 2021 and classified Class I, with 5 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 8% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 9 Sep 2024. Initiation: voluntary: firm initiated. Cordis Corporation has 23 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cordis Corporation, Miami Lakes, FL.
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."
Distribution
"Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2428-2021 | Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB | 45 units | Class I | Terminated | 22 Sep 2021 |
| Z-2429-2021 | Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB | 1610 units | Class I | Terminated | 22 Sep 2021 |
| Z-2430-2021 | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A | 18730 units | Class I | Terminated | 22 Sep 2021 |
| Z-2431-2021 | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B | 71330 units | Class I | Terminated | 22 Sep 2021 |
| Z-2432-2021 | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C | 26025 units | Class I | Terminated | 22 Sep 2021 |
Context
Other enforcement events for Cordis Corporation
All 23 events for Cordis Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 lead to marker band movement or dislodgement."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Sep 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.