| Date Initiated by Firm | July 21, 2021 |
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| Date Posted | September 15, 2021 |
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| Recall Status1 |
Terminated 3 on September 09, 2024 |
| Recall Number | Z-2431-2021 |
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| Recall Event ID |
88372 |
| 510(K)Number | K992347 |
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| Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
|
| Product | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B |
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| Code Information |
all codes |
Recalling Firm/
Manufacturer |
Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014-2802
|
| For Additional Information Contact |
786-313-2000 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Device Design |
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| 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. |
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| Quantity in Commerce | 71330 units |
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| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = DQO
|
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