MynxGrip Vascular Closure Device (6F/7F) MX6721Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M465MX67210), received between Dec 2, 2019 and Aug 18, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2020Decrease in Pressure; Decrease in Pressure

  AS REPORTED, THE BALLOON OF 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) FAILED TO INFLATE AND STAY INFLATED. THEREFORE, THE DEPLOYER APPLIED MANUAL PRESSURE WHICH WAS HELD FOR 20 MINUTES TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THERE WERE NO DAMAGED TO THE DEVICE PACKAGING, FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY OR VENOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL TYPE IS ARTERIAL. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. STICK LOCATION WAS THE FEMORAL HEAD BELOW THE INGUINAL LIGAMENT. THERE WAS NO VESSEL TORTUOSITY. THERE WAS NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE PUNCTURE SITE. THE PATIENT HOSPITALIZED WAS NOT EXTENDED AS A RESULT OF THE EVENT. THE MYNX VCD WAS PREPPED ACCORDING TO IFU INSTRUCTIONS. THE PROCEDURE USE AN ANTE-GRADE APPROACH. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420017 ↗
• MalfunctionAug 18, 2020Failure to Advance; Failure to Advance

  AFTER A DIAGNOSTIC PROCEDURE, THE 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) HAD FAILED BECAUSE IT COULD NOT ENTER THE BLOOD VESSEL. THERE WAS NO REPORTED PATIENT INJURY. HEMOSTASIS WAS ACHIEVED USING MANUAL PRESSURE. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THERE WERE NO DAMAGES NOTED TO THE DEVICE PACKAGING. THE MYNX VCD WAS PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU) INSTRUCTIONS. THE VESSEL TYPE IS ARTERIAL AND THE STICK LOCATION IS FEMORAL. A 6F UNKNOWN SHEATH WAS USED. FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY OR VENOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THERE WAS NO VESSEL TORTUOSITY, SCAR TISSUE, PVD OR CALCIUM IN THE VICINITY OF THE PUNCTURE SITE. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10419965 ↗
• MalfunctionAug 10, 2020Decrease in Pressure; Decrease in Pressure

  AS REPORTED BY THE SALES REP, THE BALLOON OF A 6F-7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) POPPED WHILE PREPPING THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AS PER LABELING. THE STAFF IN THE ROOM DID NOT SAVE THE DEVICES OR THE PACKAGING. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10387967 ↗
• MalfunctionDec 2, 2019Failure to Advance; Failure to Advance

  AS REPORTED, THE 6F-7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) DID NOT SHUTTLE DOWN ALL THE WAY. MANUAL COMPRESSION OF 30 MINUTES OR LESS WAS DONE TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT RECOVERED AFTER THE PROCEDURE. THE PATIENT WAS NOT HOSPITALIZED OR EXTENDED THE HOSPITALIZATION. THIS WAS A CASE OF DIAGNOSTIC CORONARY ANGIOGRAM. THE WAS DEVICE STORED AND HANDLED AS PER THE INSTRUCTIONS FOR USE (IFU). THE MYNX VCD WAS PREPPED ACCORDING TO IFU INSTRUCTIONS. THERE WERE NO DAMAGES NOTED ON THE DEVICE PRIOR TO USE. AN APPROACH WAS MADE FROM THE FEMORAL ARTERY WITH A 6F NON CORDIS SHEATH. THE VESSEL DIAMETER WAS 6MM. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY OR VENOGRAPHY INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THERE IS NO PRESENCE OF PERIPHERAL VASCULAR DISEASE (PVD) / CALCIUM IN THE VICINITY OF THE PUNCTURE SITE. THE PROCEDURE DID NOT USE AN ANTE-GRADE OR RETROGRADE APPROACH. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9398278 ↗

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