Summary
The FDA issued a Class I for Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B by Cordis Corporation. Reason: 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 c.
Details
Source
Device Recall
External ID
Z-2431-2021
Action Date
2021-09-22
Status
Terminated
Category
device
Product Description
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
Lot/Code Info: all codes
Quantity Affected: 71330 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-21
Company
Miami Lakes, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cordis Corporation has 15 FDA actions in our database, including 13 recalls and 2 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cordis Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cordis Corporation have FDA actions?
Cordis Corporation has 15 FDA actions in our database, including 13 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2431-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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