CLASS I Device recall · Reported 22 Sep 2021 · FDA Enforcement Report
Super Torque MB 5F Pig, Angiographic Catheter recalled by Cordis
Cordis is recalling Cordis Super Torque MB 5F Pig, Angiographic Catheter, distributed nationwide in the US. The recall was initiated on 21 Jul 2021 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2430-2021
- FDA event ID
- 88372
- Recalling firm
- Cordis, Miami Lakes, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Jul 2021
- FDA classified
- 15 Sep 2021
- Reported
- 22 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Heart & Vascular Devices
Timeline
| 21 Jul 2021 | Recall initiated by company | |
| 15 Sep 2021 | Classified by FDA | +56 days |
| 22 Sep 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
Questions about this recall
Is Super Torque MB 5F Pig, Angiographic Catheter recalled?
Yes. Cordis recalled Super Torque MB 5F Pig, Angiographic Catheter on 21 Jul 2021. The recall is Class I and its status is Terminated. Recall number Z-2430-2021.
Why was it recalled?
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.
Which lots are affected?
all codes
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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