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.
FDA Recall Z-2329-2016 · Posted 2016-08-03
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Recalling FirmAccessClosure, Inc., A Cardinal Health Company
Recall StatusTerminated
Product CodeMGB
Date Initiated2016-07-13
Date Terminated2016-08-15
Product Quantity55 units
Reason for Recall
A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
US in the states of CA, and MS.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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