6F/7F MynxGrip Vascular Closure Device recallZ-2329-2016 · AccessClosure, Inc., A Cardinal Health Company · initiated Jul 13, 2016
Class II Terminated All recalls posted in August 2016
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 AccessClosure, Inc., A Cardinal Health Company 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
A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
FDA root cause category: Process control
What the company is doing
Cardinal Health sent an Urgent Medical Device letters dated July 15, 2016 to affected customers. The letters provided the reason for recall and the exact lot number and quantity shipped to each location. Customers were instructed to quarantined affected products and complete and return the Field Action response form indicating the number of devices that will be returned. Instructions for returning the devices are included with an RMA number and Fed Ex airbill. Questions should be directed to Customer Advocacy at 408-610-6570 between 9 am and 5 pm PST.
Recall details
- Recall number
- Z-2329-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 13, 2016
- Posted by the FDA
- Aug 3, 2016
- Recalling firm
- AccessClosure, Inc., A Cardinal Health Company
- Quantity
- 55 units
- Product code
- MGB
- FDA submissions
- P040044
- Distribution
- US in the states of CA, and MS.
Product description
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 6F or 7F procedural sheath. The 6F/7F MynxGrip Vascular Closure Device is designed to achieve femoral artery and femoral vein hemostasis via delivery of an extravascular, water-soluble synthetic sealant using a balloon catheter in conjunction with a standard procedural sheath. The sealant is comprised of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the arteriotomy or venotomy. The sealant is resorbed by the body within 30-days.
Code information (models, lots, serial numbers)
Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016
Other devices under the same FDA submission
6 devices cleared under P040044 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MYNXGRIP MX6721Cordis US Corp. · Device, hemostasis, vascular3 deaths1,361 reports
- MYNXGRIP MX5021Cordis US Corp. · Device, hemostasis, vascular2 recalls915 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
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 18, 2026. Text above is shown as published by the FDA.
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