Device, Hemostasis, Vascular

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2024-01-05Open, ClassifiedLabeling Change Control

  MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.

  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.

• 2024-01-05Open, ClassifiedLabeling Change Control

  MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites

  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.

• 2023-05-18Open, ClassifiedUnder Investigation by firm

  Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices.

  The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.

• 2016-08-03TerminatedProcess control

  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.

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

• 2015-07-24TerminatedOther

  Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 610130. EXP (repackager), St. Jude Medical (OEM) Device, hemostasis, vascular

  EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

• 2013-01-25TerminatedMaterial/Component Contamination

  Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.

  Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standards of this class of product. Model Numbers EX500, EX600, and EX700.

• 2009-07-06TerminatedProcess design

  Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization.

  Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure.

• 2006-11-07TerminatedOther

  The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size.

  The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire.

• 2006-03-25TerminatedOther

  Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA.

  Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire.

• 2004-07-20TerminatedOther

  VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004), sterile (via gamma irradiation) device is sold in cardboard shelf cartons containing 5 ea. individual kits. The individual kits are packaged in a blister with Tyvek lid within a heat sealed foil pouch and fiberboard envelope. The device delivers collagen to the surface of the femoral artery following diagnostic or interventional catherization procedures using 5-8 Fr. procedural sheaths. The device is indicated for use in sealing the femoral arterial puncture site.

  Kits are missing the temporary arteriotomy locator (TAL) from the blister package.