MYNX CONTROL MX5060Recalls & reported problems

Summary

The FDA's MAUDE database contains 254 adverse event reports that list this exact device (DI 10862028000427), received between Mar 22, 2019 and Sep 29, 2026 — classified as 1 death, 16 injuries, 237 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (114 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 254 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935539 ↗
• MalfunctionSep 16, 2026Decrease in Pressure; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794142 ↗
• MalfunctionSep 16, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50786952 ↗
• MalfunctionSep 9, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692439 ↗
• MalfunctionSep 4, 2026Decrease in Pressure; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615311 ↗
• MalfunctionAug 17, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278255 ↗
• MalfunctionAug 7, 2026Failure to Fire

  As reported, when the device was attempted to be advanced into the unknown sheath, the 5F Mynx Control vascular closure device (VCD) split, and it did not advance into the sheath. The device was placed aside, and another was opened and used with no issue. There was no reported patient injury. The device was tested before putting it into the sheath. Additional information was requested but not provided. The device will not be returned for analysis.Addendum: Per product evaluation findings, the sealant was present in the manufacturing position and partially exposed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50180541 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  As reported, the sealant of a 5F Mynx Control vascular closure device (VCD) achieved hemostasis, but bleeding occurred upon ambulation. Manual compression was applied for 5 minutes, and a non-Cordis hemostatic device was placed, achieving hemostasis. There was no reported patient injury. The patient was transferred to the post-anesthesia care unit (PACU), where shadowing was noted before ambulation. Additional pressure was applied, and bleeding was observed when the patient walked after 2 hours of bed rest. At a follow-up appointment the following week, bruising was noted from the groin to the knee. The activated clotting time during the procedure was 284. There was no evidence of a pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site before use of the device. There were 2 sheath exchanges and 2 access attempts before intravascular access was achieved. The puncture site was not above the most inferior border of the inferior epigastric artery and was not below the bifurcation. The device was stored and prepared according to the instructions for use (IFU). The device was used during an interventional procedure with a retrograde approach. The deployer was

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50116372 ↗
• MalfunctionJul 27, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50035141 ↗
• MalfunctionJun 9, 2026Premature Activation

  AS REPORTED, THE DISTAL CATHETER SEALANT SLEEVE ON THE 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) MALFUNCTIONED PROXIMAL TO THE SLIT. THERE WERE NO REPORTS OF PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PER PE FINDINGS, THE SEALANT WAS PARTIALLY DEPLOYED BUT STILL MOUNTED ON THE UNIT DELIVERY SHAFT. ADDITIONALLY, A FRAYED/SPLIT/TORN CONDITION OF THE SEALANT SLEEVES WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25438777 ↗
• MalfunctionJun 8, 2026Premature Activation; Decrease in Pressure; Material Rupture

  AS REPORTED, THE BALLOON OF A 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) WOULD NOT INFLATE DURING DEVICE PREPARATION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE IFU. THE BALLOON WAS PREPPED WITH 100% SALINE. WHILE PREPPING FOR A CASE THE CORDIS MYNX WAS OPENED TO BE PLACED ON THE STERILE FIELD WHEN IT WAS NOTED TO BE BROKEN WHERE THE BALLOON SHOULD DEPLOY. THE DEVICE NEVER REACHED A PATIENT. THE DEVICE IS BEING RETURNED FOR EVALUATION. ADDENDUM: A LONGITUDINAL TEAR ON THE BALLOON AND A PARTIALLY EXPOSE OF THE SEALANT WERE FOUND ON PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429060 ↗
• MalfunctionMay 15, 2026Premature Activation

  AS REPORTED, THERE WAS NO SEALANT FOUND IN THE 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD). THE PROCEDURE WAS COMPLETED WITH MANUAL COMPRESSION. THERE WAS NO REPORTED PATIENT INJURY. THE MISSING COMPONENT WAS NOTED UPON DEPLOYMENT. THE DEVICE WAS STORED ON A SHELF IN THE MANUFACTURER¿S BOX. THE PROCEDURE WAS AN INTERVENTIONAL PROCEDURE USING A RETROGRADE APPROACH. THE USER WAS TRAINED IN THE USE OF THE DEVICE. A 5FR CORDIS BRITE TIP SHEATH INTRODUCER WAS USED. THE FEMORAL ARTERY SUITABILITY WAS VERIFIED, THE VESSEL TYPE WAS ARTERIAL, VESSEL DIAMETER WAS =5 MM, THERE WAS NO VESSEL TORTUOSITY, AND THERE WAS NO PERIPHERAL VASCULAR DISEASE OR CALCIUM AT THE PUNCTURE SITE. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION FOR 20 MINUTES. THERE WERE NO DAMAGES FOUND ON THE DEVICE OR PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. THE DEVICE WAS RETURNED FOR EVALUATION. ADDENDUM: PER PE FINDINGS, THE RECEIVED UNIT PRESENTED A PARTIALLY EXPOSED SEALANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25182623 ↗
• MalfunctionMay 11, 2026Crack

  AS REPORTED, THE CLEAR OUTER TUBE DETACHED FROM THE 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD). HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN AN INTERVENTIONAL PROCEDURE. THE DEPLOYER WAS MYNX CERTIFIED. A 5FR NON-CORDIS SHEATH INTRODUCER WAS USED. THE FEMORAL ARTERY WAS VERIFIED AS SUITABLE, INCLUDING APPROPRIATE INSERTION ANGLE, ARTERIAL VESSEL TYPE, VESSEL DIAMETER GREATER THAN OR EQUAL TO 5 MM, AND LITTLE TO NO TORTUOSITY. NO DAMAGE WAS NOTED TO THE DEVICE OR PACKAGING PRIOR TO USE. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137826 ↗
• MalfunctionMay 11, 2026Detachment of Device or Device Component

  AS REPORTED, THE 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) HAD A FAILURE. THE DEVICE INVOLVED HAD A CLEAR OUTER TUBE THAT DETACHED FROM THE DEVICE. THERE WERE NO LOOSE COMPONENTS FOUND OR RETRIEVED. HEMOSTASIS WAS ACHIEVED VIA MANUAL COMPRESSION AND PATIENT WAS DISCHARGED HOME WITH NO COMPLICATIONS. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS DIAGNOSTIC AND PERFORMED USING A RETROGRADE APPROACH BY A MYNX-CERTIFIED USER. A 5F NON-CORDIS SHEATH INTRODUCER WAS USED. THE FEMORAL ARTERY WAS VERIFIED AS SUITABLE, INCLUDING APPROPRIATE INSERTION ANGLE AND VESSEL DIAMETER GREATER THAN OR EQUAL TO 5 MM, WITH NO VESSEL TORTUOSITY REPORTED. NO DAMAGE WAS NOTED TO THE DEVICE OR PACKAGING PRIOR TO USE, AND THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AN ULTRASOUND WAS PERFORMED TO CONFIRM WHETHER ANY DEVICE COMPONENTS REMAINED IN THE ARTERY OR TRACT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136498 ↗
• MalfunctionApr 26, 2026Premature Activation

  AS REPORTED, THE SEALANT SLEEVE OF A 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) SPLIT OPEN PREMATURELY EXPOSING THE SEALANT DURING INSERTION THROUGH A HEMOSTATIC VALVE OF A NON-CORDIS SHEATH. THE DEVICE WAS REMOVED, AND ANOTHER 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) WAS USED TO SUCCESSFULLY ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS INSERTED THROUGH A SHEATH PLACED IN THE LEFT COMMON FEMORAL ARTERY FOLLOWING A PULSED FIELD ABLATION (PFA) PROCEDURE, AND RESISTANCE WAS FELT DURING INSERTION WHEN THE ISSUE WAS OBSERVED. THE SEALANT SLEEVES (CARTRIDGE ASSEMBLY) WERE NOT OUT OF POSITION AND NO DAMAGE WAS NOTED; HOWEVER, THERE WAS EXPOSURE OF THE SEALANT TO BLOOD THAT CONTACTED THE SEALANT, LIKELY DUE TO DAMAGE TO THE SEALANT SLEEVES. THE PACKAGE WAS OPENED BY A CIRCULATING NURSE, AND THE STERILE TRAY WAS REMOVED BY HAND BY THE SCRUB TECHNICIAN. NO DAMAGE WAS NOTED TO THE DEVICE OR PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE SHEATH WAS NOT KINKED OR BENT UPON REMOVAL. THE USER WAS TRAINED ON THE DEVICE. A RETROGRADE APPROACH WAS USED DURING AN ELECTROPHYSIOLOGY ABLATION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24994009 ↗
• MalfunctionApr 13, 2026Premature Activation

  AS REPORTED, THE SEALANT SLIT OF A 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) SPLIT AND ALTHOUGH INSERTION WAS ATTEMPTED, RESISTANCE WAS FELT AND THE DEVICE COULD NOT BE COMPLETELY INSERTED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS REMOVED AND ANOTHER MYNX DEVICE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. THE USER WAS POTENTIALLY UNTRAINED. THE PROCEDURE WAS AN EMBOLIZATION PERFORMED USING A RETROGRADE APPROACH. THE DEPLOYER WAS IN TRAINING WITH THE MYNX DEVICE. A CORDIS AVANTI SHEATH INTRODUCER WAS USED; LOT AND CATALOG NUMBERS WERE NOT AVAILABLE. THE FEMORAL ARTERY SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING INSERTION ANGLE, AND VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM. THERE WAS NO VESSEL TORTUOSITY AND LITTLE PERIPHERAL VASCULAR DISEASE OR CALCIUM AT THE PUNCTURE SITE. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. THE DEVICE IS BEING RETURNED FOR EVALUATION. ADDENDUM: THE SEALANT WAS FOUND EXPOSED FROM THE SEALANT SLEEVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859295 ↗
• MalfunctionApr 11, 2026Premature Activation

  AS REPORTED, THE DELIVERY SYSTEM OF A 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) MALFUNCTIONED WHEN THE PLASTIC SHEATHING AT THE DISTAL END OF THE DEVICE SPLIT WHILE BEING INSERTED THROUGH THE SHEATH. THE DEVICE WAS REMOVED, AND ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE CUSTOMER REPORTED LEFT FEMORAL ARTERY ACCESS WITH NO TORTUOSITY OR CALCIUM, AND THE DEVICE WAS ADVANCED THROUGH A NON-CORDIS SHEATH. THE PHYSICIAN WAS RE-EDUCATED TO PROVIDE SUPPORT TO THE DISTAL AREA OF THE DEVICE WHILE ADVANCING IT INTO THE SHEATH TO MITIGATE RECURRENCE. THE MYNX VASCULAR CLOSURE DEVICE (VCD) WAS USED DURING AN INTERVENTIONAL PROCEDURE USING A RETROGRADE APPROACH. THE DEPLOYER WAS TRAINED AND CERTIFIED ON THE MYNX DEVICE. FEMORAL ARTERY SUITABILITY WAS VERIFIED BY ANGIOGRAPHY, INCLUDING CONFIRMATION OF AN APPROPRIATE SHEATH INSERTION ANGLE, AND THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM. THE DEVICE WAS NOT USED IN ANY VESSEL OTHER THAN THE FEMORAL ARTERY. NO DAMAGE TO THE DEVICE OR PACKAGING WAS NOTED PRIOR TO OPENING, AND THE DEVICE WAS STORED AND PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849345 ↗
• MalfunctionApr 4, 2026Mechanical Jam

  AS REPORTED, BUTTON #1 OF THREE 5F MYNX CONTROL VASCULAR CLOSURE DEVICES JAMMED AND COULD NOT BE PUSHED DOWN AT ALL OR ALL THE WAY DOWN, AND THE SEALANT WAS NEVER DEPLOYED EXTRAVASCULAR TO THE TISSUE TRACT. THE BALLOON WORKED AND CREATED TEMPORARY HEMOSTASIS, AND THE TENSION INDICATOR ALIGNED WITH THE MARKERS ON THE HANDLE HALVES BEFORE ATTEMPTING TO DEPLOY. THERE WAS NOT ANY KINKS IN THE SHEATH OR DEVICE AFTER REMOVAL. THE SEALANT SLEEVES WERE NOTED TO BE PART OPEN AFTER REMOVAL. A NEW MYNX DEVICE FROM A DIFFERENT BOX WAS USED TO CLOSE THE GROIN. THERE WAS NO REPORTED PATIENT INJURY. IT WAS REPORTED THAT THREE FAILURES OCCURRED OUT OF ONE BOX WITH THE SAME LOT NUMBER. THE DEVICE STORAGE TEMPERATURE DID NOT EXCEED 25 °C. THE DEVICE WAS STORED AND PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE USER IS TRAINED TO THE DEVICE AND THE DEVICE WAS USED IN THE FEMORAL ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24786600 ↗
• MalfunctionApr 4, 2026Mechanical Jam

  AS REPORTED, BUTTON #1 OF THREE 5F MYNX CONTROL VASCULAR CLOSURE DEVICES JAMMED AND COULD NOT BE PUSHED DOWN AT ALL OR ALL THE WAY DOWN, AND THE SEALANT WAS NEVER DEPLOYED EXTRAVASCULAR TO THE TISSUE TRACT. THE BALLOON WORKED AND CREATED TEMPORARY HEMOSTASIS, AND THE TENSION INDICATOR ALIGNED WITH THE MARKERS ON THE HANDLE HALVES BEFORE ATTEMPTING TO DEPLOY. THERE WAS NOT ANY KINKS IN THE SHEATH OR DEVICE AFTER REMOVAL. THE SEALANT SLEEVES WERE NOTED TO BE PART OPEN AFTER REMOVAL. A NEW MYNX DEVICE FROM A DIFFERENT BOX WAS USED TO CLOSE THE GROIN. THERE WAS NO REPORTED PATIENT INJURY. IT WAS REPORTED THAT THREE FAILURES OCCURRED OUT OF ONE BOX WITH THE SAME LOT NUMBER. THE DEVICE STORAGE TEMPERATURE DID NOT EXCEED 25 °C. THE DEVICE WAS STORED AND PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE USER IS TRAINED TO THE DEVICE AND THE DEVICE WAS USED IN THE FEMORAL ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24786565 ↗
• MalfunctionApr 4, 2026Mechanical Jam

  AS REPORTED, BUTTON #1 OF THREE 5F MYNX CONTROL VASCULAR CLOSURE DEVICES JAMMED AND COULD NOT BE PUSHED DOWN AT ALL OR ALL THE WAY DOWN, AND THE SEALANT WAS NEVER DEPLOYED EXTRAVASCULAR TO THE TISSUE TRACT. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOON WORKED AND CREATED TEMPORARY HEMOSTASIS, AND THE TENSION INDICATOR ALIGNED WITH THE MARKERS ON THE HANDLE HALVES BEFORE ATTEMPTING TO DEPLOY. THERE WAS NOT ANY KINKS IN THE SHEATH OR DEVICE AFTER REMOVAL. THE SEALANT SLEEVES WERE NOTED TO BE PART OPEN AFTER REMOVAL. A NEW MYNX DEVICE FROM A DIFFERENT BOX WAS USED TO CLOSE THE GROIN. IT WAS REPORTED THAT THREE FAILURES OCCURRED OUT OF ONE BOX WITH THE SAME LOT NUMBER. THE DEVICE STORAGE TEMPERATURE DID NOT EXCEED 25 °C. THE DEVICE WAS STORED AND PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE USER IS TRAINED TO THE DEVICE AND THE DEVICE WAS USED IN THE FEMORAL ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24786559 ↗
• MalfunctionMar 16, 2026Failure to Fire

  AS REPORTED, THE SEALANT OF A 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) WAS NOT COMPLETELY DEPLOYED DURING A CLOSURE ATTEMPT. THE SEALANT OR AT LEAST PART OF IT WAS FOUND AT THE DISTAL TIP OF THE DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602651 ↗
• MalfunctionMar 13, 2026Image Orientation Incorrect; Premature Activation; Mechanical Jam

  AS REPORTED, WHILE TRYING TO DEPLOY A 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD), BUTTON 1 WOULD NOT DEPRESS EVEN THOUGH THE TENSION INDICATOR WAS LINED UP. SEVERAL ATTEMPTS TO RELEASE THE TENSION WERE MADE IN ORDER TO TRY AND REPOSITION THE LINES; HOWEVER, THE LINE GOT STUCK AND WOULD NOT MOVE BACK TO THE STARTING POSITION. BUTTON 1 WOULD NOT DEPRESS AT ALL WHICH DID NOT ALLOW THE SEALANT TO BE DELIVERED, AND THE SEALANT EVENTUALLY WAS STUCK ON THE END OF THE UNKNOWN SHEATH. ADDITIONALLY, DAMAGE WAS NOTED TO THE SEALANT SLEEVE, WHICH APPEARED FLARED AND CRUMBLED. THE MYNX CONTROL VCD AND UNKNOWN 5F SHEATH WERE REMOVED AND MANUAL COMPRESSION WAS HELD FOR 30 MINUTES. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND IT WAS USED DURING A CAROTID ANGIOGRAM PROCEDURE. THE DEPLOYER WAS TRAINED ON THE MYNX DEVICE. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE APPROPRIATE INSERTION ANGLE, AND THE VESSEL DIAMETER WAS CONFIRMED TO BE AT LEAST 5 MM, WITH NO VESSEL TORTUOSITY OR PRESENCE OF PERIPHERAL VASCULAR DISEASE OR CALCIUM NEAR THE PUNCTURE SITE. NO DAMAGE WAS NOTED TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591358 ↗
• InjuryMar 12, 2026Therapy Delivered to Incorrect Body Area

  AS REPORTED, AFTER DEPLOYMENT OF A 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) AND WAITING THREE MINUTES BEFORE REMOVING THE DEVICE, THE ARTERY DID NOT SEAL, AND THE PHYSICIAN HAD TO OPEN THE GROIN AND PROCEED TO AN EMBOLECTOMY TO RETRIEVE THE PLUG AS IT WAS GOING TO EMBOLIZE. HEMOSTASIS WAS ACHIEVED WITH 20 MINUTES OF MANUAL COMPRESSION. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED DUE TO THE EVENT, AND THE PATIENT RECOVERED. THE DEVICE WAS USED IN AN INTERVENTIONAL PROCEDURE WITH AN ANTEGRADE APPROACH USING A 5F BRITE TIP CATHETER SHEATH INTRODUCER (CSI). THE DEVICE WAS PROPERLY STORED AND OPENED IN THE STERILE FIELD AND WAS AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEPLOYER HAD OVER THREE YEARS OF EXPERIENCE USING THE DEVICE AND WAS WELL VERSED. ALL THE CORRECT STEPS WERE TAKEN DURING PREPARATION OF THE DEVICE AND DURING USE. FEMORAL ARTERY SUITABILITY WAS VERIFIED ON ANGIOGRAPHY TO CONFIRM ACCESS IN THE CORRECT VESSEL. CONTRAST OR IMAGING WAS NOT USED TO CONFIRM BALLOON PLACEMENT. THE STRIPE IN THE CENTER OF THE MYNX CONTROL VCD INDICATED THE CORRECT POSITION PRIOR TO DEPLOYMENT. THE DEPLOYER DID NOT FAIL TO UTILIZE THE TENSION INDICATOR OR MAINTAIN TENSION DURING DEP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586926 ↗
• MalfunctionMar 12, 2026Therapy Delivered to Incorrect Body Area

  AS REPORTED, IT APPEARS THERE WAS A PARTIAL INTRAVASCULAR DEPLOYMENT WHEN USING A 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD). THE DEVICE IS NOT BEING RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586584 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A PATIENT STARTED EXPERIENCING PAIN IN THE GROIN AND DEVELOPED HEMATOMA 5 DAYS AFTER AN ANGIOGRAM/ANGIOPLASTY CLOSED WITH A 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD). ON ULTRASOUND A PSEUDOANEURYSM WAS IDENTIFIED AND THE PATIENT HAD TO GO TO THE OPERATING THEATRE FOR REPAIR OF THE PSEUDOANEURYSM. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION.

  Patient problems: Pseudoaneurysm

  MAUDE report 24582282 ↗

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