MYNXGRIP MX5021Recalls & reported problems

Summary

The FDA's MAUDE database contains 915 adverse event reports that list this exact device (DI 10862028000403), received between May 7, 2018 and Sep 30, 2026 — classified as 36 injuries, 879 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (151 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall 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 16, 2026.

Recalls naming this device

1. Nov 28, 2023Open, Classified

   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.

   Z-0674-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

2. Nov 28, 2023Open, Classified

   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.

   Z-0675-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 915 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Fire

  As reported, the tamper tube of a 5F MynxGrip vascular closure device (VCD) did not deploy when the shuttle and sheath were brought back up to meet the green handle. The MynxGrip vascular closure device (VCD) was removed, and manual pressure was held. There was no reported patient injury. Ultrasound was used for access, and the patient had no vessel abnormalities. The Mynx vascular closure device (VCD) was used in an interventional procedure with a retrograde approach. The physician was reported to be well knowledgeable regarding the Mynx device. A Cordis Avanti 5F sheath was used. Femoral artery suitability was verified with ultrasound. The vessel was arterial, the vessel diameter was verified to be greater than or equal to 5 mm, and there was no vessel tortuosity or peripheral vascular disease/calcium in the vicinity of the puncture site. Hemostasis was achieved with manual pressure for 20 minutes. The user shuttled down completely, with no significant resistance when shuttling down and no unusual force applied when retracting the sheath. The advancer tube was engaged or visible. The patient had a retroperitoneal hemorrhage following a urologic procedure. The physician performed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947622 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem; Migration

  Patient problems: Rupture

  MAUDE report 50937982 ↗
• MalfunctionSep 22, 2026Activation, Positioning or Separation Problem; Unintended Movement

  As reported, the balloon of a 5F MynxGrip vascular closure devices (VCD) pulled through. There was no reported patient injury. There was no calcification. The devices will be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855305 ↗
• MalfunctionSep 21, 2026Defective Component

  As reported, a 5F MynxGrip vascular closure device (VCD) had bleeding immediately after use. There was no reported patient injury. There was no calcification. The peg was never observed. The patient was okay and doing better. The reporter stressed not getting the device wet during preparation. The devices will be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842327 ↗
• MalfunctionSep 21, 2026Decrease in Pressure; Material Rupture

  As reported, the balloon of a 5F MynxGrip vascular closure devices (VCD) pulled through. It was believed that there was a hole in the balloon. There was no patient injury. There was no calcification. The physician was experienced with the device. The devices will be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839548 ↗
• MalfunctionSep 18, 2026Decrease in Pressure; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820073 ↗
• MalfunctionSep 17, 2026Failure to Fire

  As reported, the plug of a Mynx Grip vascular closure device (VCD) could not be released normally. 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). There was no reported patient injury. The Mynx vascular closure device (VCD) was used in a diagnostic procedure with a retrograde approach. The deployer was Mynx certified. The sheath French size was 6F. The reported 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. The reported stick location was behind the femoral artery. There was no reported peripheral vascular disease (PVD) or calcium in the vicinity of the puncture site. Hemostasis was achieved by manual compression for 20 minutes. The device will be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797364 ↗
• MalfunctionSep 16, 2026Decrease in Pressure; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793963 ↗
• MalfunctionSep 15, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771799 ↗
• MalfunctionSep 14, 2026Failure to Fire; Difficult to Advance

  As reported, the white internal stylet of a 5F Mynx grip vascular closure device (VCD) was not exposed on deployment. There was no reported patient injury. The device was not returned because the account threw it away. The procedure used a retrograde approach. The deployer was Mynx certified. The sheath French size was 5F. Femoral artery 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 user shuttled down completely, however there was significant resistance when shuttling down. The advancer tube was not engaged or visible. The device is not being returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755473 ↗
• MalfunctionSep 8, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674586 ↗
• MalfunctionAug 31, 2026Component Missing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50522781 ↗
• MalfunctionAug 16, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268472 ↗
• MalfunctionAug 11, 2026Decrease in Pressure; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208319 ↗
• MalfunctionAug 10, 2026Decrease in Pressure; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50189338 ↗
• MalfunctionAug 7, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176905 ↗
• MalfunctionJul 27, 2026Failure to Advance; Failure to Fire; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50032068 ↗
• MalfunctionJun 1, 2026Failure to Advance

  AS REPORTED, A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) FAILED. THE REPORTED FAILURE WAS THAT THE WHITE TUBE DID NOT PRESENT WHEN REMOVING THE SHEATH. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION FOR 15 MINUTES. THERE WAS NO REPORTED PATIENT INJURY. THE MYNX VASCULAR CLOSURE DEVICE (VCD) WAS USED DURING A DIAGNOSTIC PROCEDURE WITH A RETROGRADE APPROACH. THE USER WAS TRAINED ON THE DEVICE. A 5F NON-CORDIS SHEATH WAS USED. THE FEMORAL ARTERY SUITABILITY AND INSERTION ANGLE WERE VERIFIED ON ANGIOGRAPHY OR VENOGRAPHY. THE DEVICE WAS USED IN THE FEMORAL ARTERY. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM. THERE WAS NO VESSEL TORTUOSITY AND NO PERIPHERAL VASCULAR DISEASE OR CALCIUM AT THE PUNCTURE SITE. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: Epistaxis

  MAUDE report 25354138 ↗
• MalfunctionJun 1, 2026Migration

  AS REPORTED, THE PLUG OF A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) DID NOT TAKE, CAME OUT WITH THE BALLOON AND WHOLE DEVICE INSTEAD OF STAYING IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348011 ↗
• MalfunctionMay 26, 2026Retraction Problem; Failure to Advance; Difficult to Advance

  AS REPORTED, WHEN TRYING TO DEPLOY A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) THE UNKNOWN SHEATH WOULD NOT COME BACK AND IT WAS REMOVED AS ONE UNIT UNDEPLOYED. THERE IS NO REPORT OF INJURY TO THE PATIENT. THE PATIENT RECOVERED. THE DEVICE WAS STORED IN THE INTERVENTIONAL RADIOLOGY DEPARTMENT. THE MYNX VCD WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). RESISTANCE/FRICTION WAS EXPERIENCED AS THE MYNX VASCULAR CLOSURE DEVICE (VCD) WAS ADVANCED THROUGH THE SHEATH. SIGNIFICANT RESISTANCE WAS EXPERIENCED WHEN SHUTTLING DOWN. EXCESSIVE FORCE WAS NOT APPLIED WHEN SHUTTLING DOWN. UNUSUAL FORCE WAS APPLIED WHEN RETRACTING THE SHEATH; THE PHYSICIAN WAS UNCOMFORTABLE WITH THE AMOUNT OF FORCE, DEFLATED THE BALLOON, AND REMOVED THE DEVICE AS ONE UNIT. THE LINE WAS FLUSHED WITH HEPARINIZED SALINE DURING THE PROCEDURE AND REMOVED AT THE END. THE PROCEDURE USED A RETROGRADE APPROACH. THE USER WAS TRAINED TO MYNX. A 5F NON-CORDIS SHEATH WAS USED. FEMORAL ARTERY SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM. THE PATIENT WAS NOT HOSPITALIZED, AND THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25281683 ↗
• MalfunctionMay 20, 2026Failure to Fire

  AS REPORTED, THE TAMPER TUBE AND SEALANT OF A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) DID NOT DEPLOY. THE PHYSICIAN PULLED THE SHEATH BACK TO THE HANDLE AND EVERYTHING CAME WITH IT. THE BALLOON WAS DEFLATED AND MANUAL PRESSURE WAS HELD FOR 25 MINUTES TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. THE USER SHUTTLED DOWN COMPLETELY WITH NO SIGNIFICANT RESISTANCE. NO UNUSUAL FORCE WAS APPLIED WHEN RETRACTING THE SHEATH. THE ADVANCER TUBE WAS NOT ENGAGED OR VISIBLE. NO DAMAGE WAS IDENTIFIED ON THE DEVICE OR PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS USED IN AN INTERVENTIONAL PROCEDURE WITH A RETROGRADE APPROACH. THE DEPLOYER HAD PRIOR EXPERIENCE USING THE MYNX DEVICE AT OTHER FACILITIES. A 5FR NON-CORDIS SHEATH INTRODUCER WAS USED. AN ANGIOGRAM OF THE PUNCTURE SITE WAS PERFORMED. THE DEVICE WAS USED IN AN ARTERIAL VESSEL WITH A VESSEL DIAMETER GREATER THAN OR EQUAL TO 5 MM. THE STICK LOCATION WAS THE LOWER ONE-THIRD OF THE FEMORAL HEAD. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25237351 ↗
• MalfunctionMay 12, 2026Failure to Fire

  AS REPORTED, THE 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) DID NOT DEPLOY CORRECTLY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150908 ↗
• MalfunctionMay 11, 2026Activation, Positioning or Separation Problem; Unintended Movement

  AS REPORTED, THE BALLOON OF A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) WAS DIRECTLY PULLED OUT FROM THE PUNCTURE SITE DURING WITHDRAWAL, RESULTING IN CLOSURE FAILURE. MANUAL COMPRESSION WAS USED FOR HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. THE OPERATOR HAD BEEN TRAINED AND WAS PROFICIENT IN THE PROCEDURE, AND THE DEVICE WAS USED ROUTINELY FOLLOWING ANGIOGRAPHY. THE DEVICE WAS DESTROYED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25141810 ↗
• MalfunctionMay 5, 2026Failure to Advance

  AS REPORTED, THE OCCLUDER SYSTEM OF A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) COULD NOT BE ADVANCED INTO PLACE (WHITE MARKER POINT), AND IT COULD NOT BE RELEASED. THE UNKNOWN SHEATH WAS NOT KINKED/BENT UPON REMOVAL. THERE WAS NO VISIBLE BEND OR DAMAGE IN THE DISTAL END OF THE BALLOON SHAFT AFTER REMOVAL. THERE WAS NO EXCESS FORCE APPLIED DURING INSERTION. HEMOSTASIS WAS ACHIEVED VIA MANUAL COMPRESSION FOR 20 MINUTES. THERE IS NO REPORTED INJURY TO THE PATIENT. THE PATIENT RECOVERED AFTER THE MYNX EVENT. THE MYNX VCD WAS USED IN A PERIPHERAL INTERVENTIONAL PROCEDURE. THE STICK LOCATION WAS THE FEMORAL ARTERY. THE PROCEDURE USED AN ANTEGRADE APPROACH. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, 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 NOR PRESENCE OF PVD / CALCIUM IN THE VICINITY OF THE PUNCTURE SITE. THE PATIENT¿S BMI WAS NOT GREATER 40 KG/M2. THE PATIENT DOES HAVE A RELEVANT MEDICAL HISTORY OF PERIPHERAL VASCULAR DISEASE (PVD). THE PATIENT'S HOSPITALIZATION WAS NOT EXTENDED BECAUSE OF THE EVENT AND THE DEPLOYER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084646 ↗
• MalfunctionApr 27, 2026Failure to Fire

  AS REPORTED, WHEN THE OPERATOR OF A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) WENT TO SHUTTLE DOWN, THE SEALANT DIDN'T DEPLOY. HEMOSTASIS WAS ACHIEVED WITH MANUAL PRESSURE IN LESS THAN 30 MINUTES. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS DIAGNOSTIC AND PERFORMED USING AN ANTEGRADE APPROACH, AND THE DEPLOYER WAS MYNX CERTIFIED. THE DEVICE WAS USED IN THE FEMORAL ARTERY, WHICH WAS VERIFIED TO HAVE A DIAMETER GREATER THAN OR EQUAL TO 5 MM, WITH NO VESSEL TORTUOSITY AND NO PRESENCE OF PERIPHERAL VASCULAR DISEASE OR CALCIUM AT THE PUNCTURE SITE. THE USER CONFIRMED THE SHUTTLE WAS FULLY DEPLOYED, NO UNUSUAL FORCE WAS APPLIED DURING SHEATH RETRACTION, AND THE ADVANCER TUBE WAS NOT ENGAGED OR VISIBLE. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999787 ↗

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-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