Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

6F/7F MynxGrip Vascular Closure Device Recalled by AccessClosure, Inc., A Cardinal Health Company Due to A total of 70 6F/7F Mynx Grip devices...

Date: July 13, 2016
Company: AccessClosure, Inc., A Cardinal Health Company
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AccessClosure, Inc., A Cardinal Health Company directly.

Affected Products

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.

Quantity: 55 units

Why Was This Recalled?

A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.

Where Was This Sold?

This product was distributed to 2 states: CA, MS

Affected (2 states)Not affected

About AccessClosure, Inc., A Cardinal Health Company

AccessClosure, Inc., A Cardinal Health Company has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report