Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported September 22, 2021
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cordis Corporation recalled Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785… - a critical-severity action.
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785… was recalled by Cordis Corporation in September 22, 2021. Reason: Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a …. Check the official notice for the remedy. Verify recall #Z-2428-2021 with the FDA Devices before acting.
The recall
Cordis Corporation issued this critical-severity FDA Devices recall-Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a ….
- Critical
- severity level
- 45 units
- affected scope
- Class I
- classification
- September 22, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2428-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2428-2021) was formally reported on September 22, 2021, with the manufacturer initiating the action on July 21, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Cordis Corporation is listed as the recalling firm, operating out of Miami Lakes, FL. Federal records list the affected scope as 45 units.
The documented reason for this recall is: 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 l… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
45 units
Related Recalls
6
3 from same agency
Product description
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2428-2021 |
| Date reported | September 22, 2021 |
| Date initiated | July 21, 2021 |
| Recalling firm | Cordis Corporation |
| Firm location | Miami Lakes, FL |
| Affected scope | 45 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2428-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB. Recalled by Cordis Corporation. Units affected: 45 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on September 22, 2021. Severity: Critical. Recall number: Z-2428-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2428-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 22, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.