MYNXGRIP MX6721Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,361 adverse event reports that list this exact device (DI 10862028000410), received between May 7, 2018 and Sep 30, 2026 — classified as 3 deaths, 89 injuries, 1,269 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (309 reports).

3 other recalls cover devices cleared under the same FDA submission (P040044); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,361 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Fire

  As reported, the polyethylene glycol (PEG) plug of a 6/7F Mynx Grip vascular closure device (VCD) would not deploy after several attempts. Hemostasis was achieved by manual compression. There was no reported patient injury. The user shuttled down completely, and there was no significant resistance when shuttling down. The advancer tube was not engaged or visible. No damage was found on the device or device packaging prior to opening. The device was stored and prepared in accordance with the instructions for use (IFU). A retrograde approach was used. The deployer was Mynx certified. The vessel type was arterial, the vessel diameter was verified to be greater than or equal to 5 mm, and the stick location was the right femoral artery. The device will not be returned for evaluation as it was discarded.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947596 ↗
• MalfunctionSep 28, 2026Failure to Fire

  As reported, a 6F/7F MynxGrip vascular closure devices (VCD) failed to deploy the plug properly. Manual compression was held for 15 minutes and there were no reported injuries to the patient. The user shuttled down completely, there was no significant resistance during shuttle down, no unusual force was applied when retracting the sheath, there were no kinks in the sheath or device after removal, and the device storage temperature did not exceed 25 °C. A non-Cordis sheath 5F × 10 was used. The device was used in the common femoral artery (CFA). Femoral artery suitability, including the vascular sheath introducer insertion angle, was verified on angiography or venography. The vessel type was arterial, the vessel diameter was verified to be at least 5 mm, there was little to no vessel tortuosity, and there was no peripheral vascular disease (PVD) or calcium near the puncture site. The device was stored and prepared according to the instructions for use (IFU). The Mynx vascular closure device (VCD) was used during an interventional peripheral procedure using a retrograde approach. The deployer was Mynx certified. The devices will not be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914920 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914325 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910514 ↗
• MalfunctionSep 25, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900422 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hematoma

  MAUDE report 50873867 ↗
• MalfunctionSep 23, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863010 ↗
• MalfunctionSep 22, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859669 ↗
• MalfunctionSep 22, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859503 ↗
• MalfunctionSep 21, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847351 ↗
• MalfunctionSep 21, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846653 ↗
• MalfunctionSep 18, 2026Migration

  As reported, the plug of a 6/7F MynxGrip vascular closure device (VCD) was pulled out of the body when the device was removed after LSD, resulting in closure failure. The sealant was deployed to the proper location and subsequently dislodged. The vessel depth was not shallow. The sealant was deployed outside the vessel wall at the femoral artery puncture site; it was not completely above the skin and was partially in the tissue. The guidewire inside the balloon was found to be loop-shaped with a large outer diameter, as shown in the attachment. Hemostasis was achieved by manual compression for 15 minutes. There was no reported patient injury. The operator was highly experienced. The referenced guidewire was the soft guidewire that is part of the MynxGrip device and connects the atraumatic tip to the delivery shaft; it was a component of the MynxGrip device itself and was located between the atraumatic tip and the plug-release delivery shaft. No damage was found on the device or device packaging prior to opening. The advancer tube was held in place while the balloon was removed from the access site. A retrograde approach was used. The deployer was Mynx certified. An 11F non-Cordis s

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818008 ↗
• MalfunctionSep 17, 2026Failure to Fire

  As reported, the plug of a 6/7 Mynx Grip vascular closure device (VCD) was not released. There was no reported patient injury. The user shuttled down completely. There was no significant resistance when shuttling down, and no unusual force was applied when retracting the sheath. The advancer tube was engaged or visible. No damage was found on the device or device packaging prior to opening. The device was stored and prepared in accordance with the instructions for use (IFU). The Mynx VCD was used in a diagnostic procedure with a retrograde approach. The deployer was Mynx certified. The sheath introducer information was unknown, except that the sheath size was 6F. The vascular sheath introducer insertion angle was 30¿45 degrees. The vessel was arterial, and the device was used in the femoral artery. The vessel diameter was greater than 5 mm. There was no vessel tortuosity. The puncture location was the femoral artery. There was no peripheral vascular disease (PVD) or calcium in the vicinity of the puncture site.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797460 ↗
• MalfunctionSep 16, 2026Failure to Fire

  As reported, the plug of a 6/7F Mynxgrip vascular closure device (VCD) could not be released. There was no reported patient injury. The procedure was interventional and used a retrograde approach. The deployer was Mynx certified. The sheath introducer information was unknown; the sheath size was 6F. The vascular sheath introducer insertion angle was 30-45 degrees. The vessel was the femoral artery and was greater than 5 mm in diameter. There was no vessel tortuosity and no peripheral vascular disease (PVD)/calcium in the vicinity of the puncture site. Hemostasis was achieved with manual compression for 20 minutes. The user shuttled down completely with no significant resistance, and no unusual force was applied when retracting the sheath. The advancer tube was not visible. The device is being returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50786355 ↗
• MalfunctionSep 15, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777953 ↗
• MalfunctionSep 15, 2026Failure to Fire

  As reported, the white internal stylet of a 6/7F Mynx Grip vascular closure device (VCD) was not exposed during deployment. There was no reported patient injury. The user shuttled down completely, and significant resistance was encountered while shuttling down. The advancer tube was not engaged or visible. No damage was found on the device or device packaging prior to opening. The device was stored and prepped in accordance with the instructions for use (IFU). A retrograde approach was used. The deployer was Mynx certified. The femoral artery¿s suitability was verified on angiography or venography, including the vascular sheath introducer insertion angle of 30¿45 degrees. The vessel was arterial, and the vessel diameter was verified to be greater than or equal to 5 mm. The stick location was the common femoral artery (CFA).The device will be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774405 ↗
• MalfunctionSep 8, 2026Decrease in Pressure; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667787 ↗
• MalfunctionSep 8, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658897 ↗
• MalfunctionAug 25, 2026Decrease in Pressure; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50432537 ↗
• MalfunctionAug 24, 2026Decrease in Pressure; Material Puncture/Hole; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420819 ↗
• MalfunctionAug 23, 2026Decrease in Pressure; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50395257 ↗
• MalfunctionAug 19, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50324278 ↗
• MalfunctionAug 17, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268678 ↗
• MalfunctionAug 14, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255945 ↗
• MalfunctionAug 9, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50188204 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040044. One submission often covers many models, so check the product and lot details in each record.

• Z-0675-2024 · Nov 28, 2023 · Open, Classified
  MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
• Z-0674-2024 · Nov 28, 2023 · Open, Classified
  MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
• Z-2329-2016 · Jul 13, 2016 · Terminated
  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 v