MYNX CONTROL MX6760Recalls & reported problems

Summary

The FDA's MAUDE database contains 280 adverse event reports that list this exact device (DI 10862028000434), received between Feb 12, 2019 and Sep 28, 2026 — classified as 2 deaths, 39 injuries, 239 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (82 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 280 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915140 ↗
• MalfunctionSep 25, 2026Delivered as Unsterile Product; Unsealed Device Packaging

  As reported, the inside of the packaging for a 6/7F Mynx Control vascular closure device (VCD) was not closed, which caused the device to fall on the floor. There was no reported patient injury. The customer stated that usually all 3 tabs are sealed. The device will not be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50901186 ↗
• MalfunctionSep 22, 2026Material Frayed; Failure to Fire; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859099 ↗
• MalfunctionSep 20, 2026Decrease in Pressure; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834697 ↗
• MalfunctionSep 16, 2026Premature Activation

  As reported, the PEG of a 6F/7F Mynx Control vascular closure device (VCD) was noted to already be deployed after the balloon was prepped. There was no reported patient injury. The device was not used on the patient. The device had been opened to close the right femoral artery after a right leg intervention. The users were experienced. The device will be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788133 ↗
• DeathSep 15, 2026Adverse Event Without Identified Device or Use Problem

  As reported, a 6/7F Mynx Control vascular closure device (VCD) was deployed by the physician, and the patient later experienced complications. There was no reported patient injury. The patient had been discharged home before the complications occurred. The physician was notified, and the patient underwent emergency surgery. The patient subsequently expired. The device will be returned for evaluation.

  Patient problems: Insufficient Information

  MAUDE report 50772060 ↗
• MalfunctionSep 14, 2026Premature Activation

  As reported, after prep, the user was in the process of inserting the atraumatic tip of a 6/7F Mynx Control vascular closure device (VCD) into the sheath hub, when the user noticed fraying of the proximal tip of the sealant housing with exposed sealant. A new device from the same lot was prepared and deployed without complication. The dvice was removed from table and new Mynx Control Vascular Closure Device 6F/7F was deployed without any issues or complications. There was no reported patient injury. The device was removed from packaging by handle and prepped according to the instructions for use (IFU) standards by a trained user. The device was inspected for damage when removed from the package, and no damage to the packaging or device was noted at that time. The device never entered the sheath. A6F non-Cordis sheath was used. The device was never inserted into the patient or deployed. Femoral artery suitability, including a vascular sheath introducer insertion angle of 30¿45 degrees, was verified on angiography. The vessel diameter was verified to be greater than or equal to 5 mm. There was no peripheral vascular disease (PVD) or calcium in the vicinity of the puncture site. The d

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754847 ↗
• MalfunctionSep 14, 2026Difficult to Remove

  As reported, button 2 of a 6F/7F Mynx Control vascular closure device (VCD) could be pressed down but would immediately pop back up. There was no reported patient injury. The balloon was filled with a mixture of contrast and saline and observed under X-ray during deployment and balloon deflation. The device was stored and prepared according to the instructions for use (IFU), and no device or package damage was noted prior to use. The device was used in an angiography procedure with intervention using a retrograde approach. The physician was trained on the Mynx device. A 5F non-Cordis sheath was used. Vessel suitability, including a 30¿45 degree vascular sheath introducer insertion angle, was verified on venography, and the vessel diameter was verified to be at least 5 mm. Hemostasis was achieved with the same Mynx device, and sealant deployment was successful; however, button 2 would return to the start position once pressed. The balloon was not inverted. The balloon was observed to inflate and deflate under X-ray guidance with a contrast and saline mixture in the balloon, and no problems with the balloon were reported. The device will not be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754777 ↗
• MalfunctionSep 10, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716247 ↗
• MalfunctionSep 9, 2026Premature Activation

  As reported, the sealant of a 6F¿7F Mynx Control vascular closure device (VCD) prematurely swelled during introduction into the sheath and became stuck, preventing advancement through the sheath. The device was removed due to inability to advance, and hemostasis was achieved by manual compression for less than 30 minutes. There was no reported patient injury. The device was stored and prepared according to the instructions for use, and the user was trained to the device. The device was inspected upon removal from the package, and no damage to the device or packaging was noted. A 6F non-Cordis catheter sheath introducer was used. The sheath was flushed prior to device insertion, and the device was purged of air prior to use, with no delay between preparation and insertion. The sealant was not exposed prior to insertion. Resistance was encountered during insertion into the sheath. No evidence of intravascular sealant was observed. The device was returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690797 ↗
• MalfunctionSep 8, 2026Decrease in Pressure; Material Rupture

  As reported, the balloon of a 6F/7F Mynx Control vascular closure device (VCD) popped when attempting to deploy the device. Manual compression was applied. There was no reported patient injury. The physician believed the failure was due to the anatomy and calcium. No patient harm occurred, and hemostasis was achieved with manual compression. A retrograde approach was used. The deployer was trained and described as a long-time supporter. Calcium was present however the severity was unknown. The balloon reportedly popped during deployment while inside the patient when attempting to position/deploy the device. Based on the physician¿s description, the balloon popped while attempting deployment; it was believed to have occurred after pullback to the arteriotomy, although this could not be definitively confirmed. The device was not retained for return evaluation. The device will not be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668576 ↗
• MalfunctionSep 1, 2026Therapy Delivered to Incorrect Body Area

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546379 ↗
• MalfunctionAug 11, 2026Decrease in Pressure; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209738 ↗
• MalfunctionAug 7, 2026Therapy Delivered to Incorrect Body Area

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50169471 ↗
• MalfunctionJun 23, 2026Premature Activation

  AS REPORTED, THE PLUG OF A 6/7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) BECAME DEFORMED AND COULD NOT BE DELIVERED. AFTER REMOVAL, THE SEALANT EXHIBITED CHANGES IN COLOR AND FORM, BECOMING DARKER AND HARDENED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE, AND THE ISSUE WAS IDENTIFIED DURING PATIENT USE WITH NO DAMAGE NOTED PRIOR TO USE. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION FOR 20 MINUTES, AND THE DEPLOYER WAS MYNX CERTIFIED. THE PROCEDURE WAS INTERVENTIONAL USING AN ANTEGRADE APPROACH. ANGIOGRAPHY CONFIRMED FEMORAL ARTERY SUITABILITY WITH APPROPRIATE INSERTION ANGLE, VESSEL DIAMETER WAS =5 MM, AND THERE WAS NO VESSEL TORTUOSITY OR PRESENCE OF PERIPHERAL VASCULAR DISEASE OR CALCIFICATION. THE DEVICE IS BEING RETURNED FOR EVALUATION. ADDENDUM: THE SEALANT WAS EXPOSED FROM THE SEALANT SLEEVES ON PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25595638 ↗
• MalfunctionJun 15, 2026Therapy Delivered to Incorrect Body Area

  AS REPORTED, THE SEALANT OF A 6/7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) WAS REMOVED ALONG WITH THE DEVICE. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS IN LESS THAN 30 MINUTES. THERE WAD NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE IFU, THE USER WAS TRAINED, AND THE DEVICE WAS INSPECTED AND PREPPED AS STATED IN THE IFU WITH NO ABNORMALITIES DETECTED. THE DEVICE STORAGE TEMPERATURE WAS CONTROLLED IN THE STORAGE ROOM. THE DEVICE WAS USED FOR A DIAGNOSTIC LEFT HEART CATHETERIZATION. A NON-CORDIS 6F SHEATH WAS USED. THE DEVICE WAS INSERTED INTO A SHEATH, THE BALLOON WAS INFLATED AND PULLED BACK, BUTTON 1 WAS DEPRESSED, 2 MINUTES ELAPSED, THE BALLOON WAS DEFLATED, AND BUTTON 2 WAS PRESSED. THE SEALANT DEPLOYED UNDER THE SKIN, ON TOP OF THE ARTERIOTOMY, UPON DEPRESSING BUTTON 1. THE SEALANT WAS DISLODGED FROM THE ARTERIOTOMY UPON REMOVAL OF THE DEVICE ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) PROTOCOL. THE SEALANT DID NOT STICK TO THE DEVICE. BUTTON 1 WAS FULLY DEPRESSED, THE BALLOON WAS FULLY DEFLATED, BUTTON 2 WAS FULLY DEPRESSED, AND NO ADDITIONAL RESISTANCE WAS NOTED. ACCESS WAS REPORTED AS A GOOD STICK WITH A VESSEL LARGE ENOUGH FOR MYN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25501642 ↗
• MalfunctionJun 8, 2026Decrease in Pressure; Material Rupture

  AS REPORTED, THE BALLOON OF A 6F/7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) RUPTURED AFTER BALLOON EXPANSION, WHILE PULLING BACK AT AN ANGLE ALIGNED WITH THE PUNCTURE ANGLE. ANOTHER UNKNOWN PRODUCT WAS OPENED FOR HEMOSTASIS, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOON DID NOT LOSE PRESSURE DURING PREPARATION OR PATIENT USE. THE BALLOON DID NOT LOSE PRESSURE AFTER BEING PULLED TO THE ARTERIOTOMY. THE PROCEDURE WAS TREATING THE SUPERFICIAL FEMORAL ARTERY (SFA) AND USED AN IPSILATERAL ANTEGRADE PUNCTURE. THE DEVICE WAS PREPPED AND STORED PER THE INSTRUCTIONS FOR USE (IFU). A NON-CORDIS SHEATH INTRODUCER WAS USED WITH THE DEVICE. THERE WAS NO PRIOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), STENT, OR VASCULAR GRAFT IN THE COMMON FEMORAL ARTERY. THERE WAS NO VISIBLE DAMAGE TO THE SHEATH AFTER REMOVAL, AND THERE WAS NO VISIBLE DAMAGE AT THE DISTAL END OF THE SHEATH AFTER REMOVAL. THERE WAS NO PRESENCE OF PERIPHERAL VASCULAR DISEASE (PVD) OR CALCIUM IN THE VICINITY OF THE PUNCTURE SITE. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM. THERE WAS NO VESSEL TORTUOSITY. THE PATIENT WAS NOT HOSPITALIZED, AND HOSPITALIZATION WAS N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435773 ↗
• MalfunctionJun 1, 2026Decrease in Pressure; Material Rupture

  AS REPORTED, THE BALLOON OF A 6F/7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) ¿BURSTED¿ DURING DEPLOYMENT. THERE IS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25352238 ↗
• MalfunctionMay 11, 2026Premature Activation

  AS REPORTED, THE SEALANT OF A 6/7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) DEPLOYED PREMATURELY DURING THE CASE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT RETURNED BECAUSE IT WAS THROWN AWAY. THE DEPLOYER WAS MYNX TRAINED. MANUAL COMPRESSION DURATION WAS UNKNOWN. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. THE SEALANT WAS PREMATURELY EXPOSED OR DEPLOYED; HOWEVER, THE TIMING OF WHEN THIS OCCURRED COULD NOT BE DETERMINED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135429 ↗
• MalfunctionApr 28, 2026Defective Component

  AS REPORTED, THE TENSION INDICATOR OF A 6F¿7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) NEVER LINED UP. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS INTERVENTIONAL AND PERFORMED USING A RETROGRADE APPROACH. A NON-CORDIS 6F SHEATH INTRODUCER WAS USED. FEMORAL ARTERY SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING INSERTION ANGLE, AND THE VESSEL DIAMETER WAS CONFIRMED TO BE GREATER THAN OR EQUAL TO 5 MM. VESSEL TORTUOSITY WAS UNKNOWN, AND THERE WAS NO PRESENCE OF PERIPHERAL VASCULAR DISEASE OR CALCIUM AT THE PUNCTURE SITE. HEMOSTASIS WAS ACHIEVED VIA MANUAL COMPRESSION FOR 10 MINUTES. THE PATIENT RECOVERED FOLLOWING THE EVENT. THE DEVICE AND PACKAGING WERE INSPECTED PRIOR TO USE WITH NO ANOMALIES NOTED. THE SEALANT WAS NOT DISLODGED FROM THE VENOTOMY. THE DEVICE STORAGE TEMPERATURE DID NOT EXCEED 25 °CELSIUS. NO RESISTANCE WAS NOTED DURING USE OF THE DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015039 ↗
• MalfunctionApr 27, 2026Therapy Delivered to Incorrect Body Area

  AS REPORTED, AFTER INFLATION OF THE BALLOON OF A 6F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) THE DEVICE WAS PULLED BACK AGAINST THE ARTERY AND REMOVED FROM THE BODY WITHOUT SUCCESSFUL DEPLOYMENT. MANUAL PRESSURE WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS INSERTED INTO THE SHEATH SUCCESSFULLY WITH NO COMPLICATIONS AND POSITIONED AROUND THE SHEATH CATCH. POST-PROCEDURE, IT WAS FOUND THE BALLOON WAS NOT INFLATED TO THE CORRECT INDICATION BY THE USER. THERE WERE NO COMPLICATIONS REPORTED. A RETROGRADE APPROACH WAS USED. THE OPERATOR WAS IN TRAINING WITH THE DEVICE. A 6FR NON-CORDIS SHEATH INTRODUCER 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. THERE WAS NO VESSEL TORTUOSITY. THERE WAS NO PRESENCE OF PERIPHERAL VASCULAR DISEASE OR CALCIUM AT THE PUNCTURE SITE. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO SHALLOW VESSEL DEPTH. THERE WAS NO RESISTANCE NOTED DURING USE. THE DEVICE WAS ACCIDENTALLY DISCARDED AFTER THE PROCEDURE AND WILL NOT BE RETURN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25003771 ↗
• MalfunctionApr 24, 2026Material Frayed; Premature Activation; Material Split, Cut or Torn

  AS REPORTED, A 6F/7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) KINKED AND BUNCHED UP AT THE TIP OF THE DEVICE DURING INSERTION. THE TIP COLLAPSED AND THE DEVICE COULD NOT BE INSERTED. AN IMAGE WAS PROVIDED WHICH SHOWS THE SEALANT SLEEVES ARE SPLIT FROM THE CORE WIRE AND THE SEALANT IS UNCOVERED. A SECOND 6F/7F MYNX CONTROL VCD WAS INSERTED AND DEPLOYED WITHOUT ISSUE. HOWEVER, THE CLOSURE DID NOT TAKE, AND MANUAL COMPRESSION WAS HELD FOR APPROXIMATELY 10-15 MINUTES. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE FIRST DEVICE WAS PROPERLY PREPPED AND INSERTED CORRECTLY. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987357 ↗
• MalfunctionApr 24, 2026Defective Component

  AS REPORTED, A 6F/7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) KINKED AND BUNCHED UP AT THE TIP OF THE DEVICE DURING INSERTION. THE TIP COLLAPSED AND THE DEVICE COULD NOT BE INSERTED. AN IMAGE WAS PROVIDED WHICH SHOWS THE SEALANT SLEEVES ARE SPLIT FROM THE CORE WIRE AND THE SEALANT IS UNCOVERED. A SECOND 6F/7F MYNX CONTROL VCD WAS INSERTED AND DEPLOYED WITHOUT ISSUE. HOWEVER, THE CLOSURE DID NOT TAKE, AND MANUAL COMPRESSION WAS HELD FOR APPROXIMATELY 10-15 MINUTES. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE FIRST DEVICE WAS PROPERLY PREPPED AND INSERTED CORRECTLY. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987326 ↗
• MalfunctionApr 20, 2026Decrease in Pressure; Material Rupture

  AS REPORTED, THE BALLOON OF A 6/7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) RUPTURED WHEN INFLATED. HEMOSTASIS WAS ACHIEVED USING ANOTHER MYNX VASCULAR CLOSURE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT RETURNED BECAUSE IT WAS DISCARDED BY STAFF. THE PROCEDURE WAS DIAGNOSTIC USING A RETROGRADE APPROACH. THE DEPLOYER WAS IN TRAINING ON THE DEVICE. A 6F NON-CORDIS SHEATH INTRODUCER WAS USED. THE FEMORAL ARTERY SUITABILITY WAS VERIFIED, THE VESSEL TYPE WAS ARTERIAL, THE VESSEL DIAMETER WAS =5 MM, THERE WAS NO VESSEL TORTUOSITY, AND THE PRESENCE OF PERIPHERAL VASCULAR DISEASE OR CALCIUM WAS UNKNOWN. . THE DEVICE WAS STORED AND PREPARED ACCORDING TO INSTRUCTIONS FOR USE. THE BALLOON LOST PRESSURE WHILE INSIDE THE PATIENT AFTER INFLATION, THE DEVICE WAS REMOVED, AND A SECOND DEVICE WAS USED. THERE WAS NO PRIOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, STENT, OR VASCULAR GRAFT, AND THE BALLOON DID NOT LOSE PRESSURE AFTER BEING PULLED TO THE ARTERIOTOMY. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925738 ↗
• MalfunctionApr 13, 2026Therapy Delivered to Incorrect Body Area

  AS REPORTED, THE PLUG OF A 6/7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) DID NOT GET RELEASED FROM THE HANDLE DURING DEPLOYMENT IN THE RIGHT GROIN. THE DEVICE WAS WITHDRAWN, AND MANUAL PRESSURE WAS APPLIED FOR 30 MINUTES TO PREVENT FURTHER BLEEDING. THERE WAS A REPORTED PATIENT INJURY OF SMALL HEMATOMA IN THE RIGHT GROIN THAT WAS CAUSED BECAUSE OF THE FAILED DEPLOYMENT. THE PATIENT WAS ON A BLOOD THINNER. THE VENDOR WAS NOTIFIED BY THE CLINICAL SITE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865214 ↗

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