MYNXGRIP recallZ-0675-2024 · Cordis US Corp · initiated Nov 28, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cordis US Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
FDA root cause category: Labeling Change Control
What the company is doing
Cordis issued an Urgent MEDICAL DEVICE RECALL notice to its consignees on 11/28/2023 via via FEDEX. The notice explained the issue and requested the return of any affected product in inventory. For questions related to the recall and/or acknowledgement form that are not adequately addressed in the letter, please contact Cordis QA at: [email protected] or call Cordis Customer Support 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT.
Recall details
- Recall number
- Z-0675-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 28, 2023
- Posted by the FDA
- Jan 5, 2024
- Recalling firm
- Cordis US Corp
- Quantity
- 70 units
- Product code
- MGB
- FDA submissions
- P040044
- Distribution
- US: NC, WV, TN, MS, MI, OH, CA
Product description
MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
Code information (models, lots, serial numbers)
UDI/DI 10862028000403, Lot numbers: F2322903
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MYNXGRIP MX5021Cordis US Corp. · Device, hemostasis, vascular2 recalls915 reports
Product lines
Other devices under the same FDA submission
5 devices cleared under P040044 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- MYNXGRIP MX6721Cordis US Corp. · Device, hemostasis, vascular3 deaths1,361 reports
- MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12F MX61260Cordis US Corp. · Device, Hemostasis, Vascular293 reports
- MYNX CONTROL MX6760Cordis US Corp. · Device, hemostasis, vascular2 deaths280 reports
- MYNX CONTROL MX5060Cordis US Corp. · Device, hemostasis, vascular1 death254 reports
- MynxGrip Vascular Closure Device (6F/7F) MX6721Access Closure, Inc. · Device, Hemostasis, Vascular4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93617).
- Z-0674-2024 · Open, ClassifiedMYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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