MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12F MX61260Recalls & reported problems

Summary

The FDA's MAUDE database contains 293 adverse event reports that list this exact device (DI 10705032090278), received between Aug 13, 2024 and Sep 25, 2026 — classified as 134 injuries, 159 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (43 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 25 most recent of 293 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Decrease in Pressure; Material Puncture/Hole

  As reported, the balloon of a 6F¿12F Mynx Control Venous vascular closure device (VCD) was found to have a micro hole after the device came out of the body and the balloon was observed to be deflated. The site was sutured, and manual pressure was held for 10 minutes for hemostasis. There was no reported patient injury. The device was prepped per the instructions for use (IFU), advanced through the sheath, and attached around the side port of the sheath. The physician inflated the balloon and viewed the inflation indicator as white, black, and white, and it appeared ready to use. As the physician pulled back the device along with the sheath, the device came out of the body. The balloon was deflated, and the inflation indicator was no longer visible. When the balloon was tested again for inflation, a small stream of saline was observed coming from a micro hole in the balloon. The Mynx vascular closure device (VCD) was used in an electrophysiology (EP) ablation procedure with a retrograde approach. The deployer¿s Mynx training status was reported as ¿excellent.¿ A Cordis Avanti 10F sheath was used. Femoral vessel suitability, including the vascular sheath introducer insertion angle of

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892866 ↗
• MalfunctionSep 22, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858187 ↗
• MalfunctionSep 22, 2026Defective Component

  As reported, a 6F¿12F Mynx Control Venous vascular closure device (VCD) locked out, and the tension indicator line would not move despite the device being pulled all the way to the venotomy during an atrial fibrillation ablation procedure. The device could not be deployed. The balloon was deflated, and manual pressure was held for approximately 8 minutes. There was no reported patient injury. Access was obtained through the left and right femoral veins. The left femoral vein had 2 access sites, 10F and 7F, approximately 6mm apart. A Mynx Control Venous vascular closure device was deployed at the 10F site without issue before the reported event. The reported issue occurred at the 7F left femoral vein access site. A Mynx Control Venous vascular closure device was subsequently deployed at an 8F left femoral vein access site without issue. Protamine 100mg was administered. No oozing was observed at the site, and the patient remained in recovery per bedrest protocol. No damage was found on the device or device packaging prior to opening. The Mynx vascular closure device (VCD) was used in an interventional atrial fibrillation (AFib) ablation electrophysiology (EP) case using an antegrade

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856874 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50796649 ↗
• MalfunctionSep 16, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794109 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50619762 ↗
• MalfunctionSep 2, 2026Decrease in Pressure

  As reported, two 6F Mynx Control venous vascular closure devices (VCD) were used. The first Mynx, the balloon ruptured during prep. The second Mynx, the sheath was cracked near the balloon. There was no reported injury to the patient. Other procedural details were requested but were not provided. The devices will be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568655 ↗
• MalfunctionAug 31, 2026Deflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50520361 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  As reported in the Move study, a patient experienced pseudoaneurysm after the use of four 6-12F Mynx Control Venous vascular closure devices (VCD). Discharge ultrasound revealed the pseudoaneurysm in the right groin which required thrombin injection and extension of hospitalization. The devices were used after an atrial fibrillation (AFib) ablation using a non-Cordis device. Venous access was obtained with the use of ultrasound. Two 8F sheaths and an 8.5F sheath were used in the right groin and one 10F sheath was used in the left groin. The devices were successfully deployed. The patient received 28000 units of intraprocedural heparin and 50mg of protamine was administered. The activated clotting time (ACT) was 48 seconds. Procedural time was 52 minutes, and time to ambulation was approximately two hours. The device was stored and prepped according to the IFU. The deployer was trained in the use of the device. The devices will not be returned for evaluation.

  Patient problems: Pseudoaneurysm

  MAUDE report 50498861 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  As reported in the Move study, a patient experienced groin swelling and a 1.4cm hematoma after the use of four 6-12F Mynx Control Venous vascular closure devices (VCD). Medication was provided for treatment. The devices were used after an SVT ablation using a non-Cordis device. Venous access was obtained in both groins with the use of ultrasound. An 8F and10F sheath were used in the left groin and a 6F and 8F sheath were used on the right groin. Approximately 7mm of distance was between access sites. Hemostasis was maintained after 5 minutes. The devices were successfully deployed. The patient received intraprocedural 11000 heparin and 50mg of protamine was administered. The activated clotting time (ACT) was 276 seconds. Procedural time was 86 minutes, and time to ambulation was approximately two hours. The device was stored and prepped according to the IFU. The deployer was trained in the use of the device. The devices will not be returned for evaluation.

  Patient problems: Hematoma

  MAUDE report 50497740 ↗
• MalfunctionAug 24, 2026Premature Activation; Decrease in Pressure; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420793 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  As reported in the Move study, a patient experienced ecchymosis, pain and bleeding after the use of three 6-12F Mynx Control Venous vascular closure devices (VCD). Bleeding required transfusion, surgical intervention, or rehospitalization. The patient was prescribed pain medication to take as needed after discharge. The device was used after an atrial fibrillation (AFib) ablation using a non-Cordis device. Venous access was obtained with the use of ultrasound with one access site in the right leg and two in the left. A 9F sheath was used in the right groin and a 7F and 10F were used in the left. The devices were successfully deployed. The patient received 15000 units of intraprocedural heparin and 100mg of protamine was administered. The activated clotting time (ACT) was 331 seconds. Procedural time was 64 minutes, and time to ambulation was approximately two hours. The device was stored and prepped according to the IFU. The deployer was trained in the use of the device. The devices will not be returned for evaluation.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50177242 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  As reported in the Move study, a patient experienced groin swelling after the use of three 6-12F Mynx Control Venous vascular closure device (VCD) in the right groin. An ultrasound was completed on follow up visit showing a 3.1 X 1.3 X 0.7 complex debris filled collection which is likely hematoma. Medication was provided as treatment. The device was used after an atrial fibrillation (AFib) ablation using a non-Cordis device. Venous access was gained with the use of ultrasound. One 7F, one 8F and one 10F sheath were use with approximately 6mm in between sites. Hemostasis was maintained after 5 minutes. The devices were successfully deployed. The patient received 23000 units of intraprocedural heparin and 50mg of protamine was administered. The activated clotting time (ACT) was 383 seconds. Procedural time was 33 minutes, and time to ambulation was 2.28 hours. The device was stored and prepped according to the IFU. The deployer was trained in the use of the device. The devices will not be returned for evaluation.

  Patient problems: Hematoma

  MAUDE report 50021510 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  As reported in the Move study, a patient experienced groin swelling after the use of three 6-12F Mynx Control Venous vascular closure device (VCD) in the right groin. An ultrasound was completed on follow up visit showing a 3.1 X 1.3 X 0.7 complex debris filled collection which is likely hematoma. Medication was provided as treatment. The device was used after an atrial fibrillation (AFib) ablation using a non-Cordis device. Venous access was gained with the use of ultrasound. One 7F, one 8F and one 10F sheath were use with approximately 6mm in between sites. Hemostasis was maintained after 5 minutes. The devices were successfully deployed. The patient received 23000 units of intraprocedural heparin and 50mg of protamine was administered. The activated clotting time (ACT) was 383 seconds. Procedural time was 33 minutes, and time to ambulation was 2.28 hours. The device was stored and prepped according to the IFU. The deployer was trained in the use of the device. The devices will not be returned for evaluation.

  Patient problems: Hematoma

  MAUDE report 50021217 ↗
• MalfunctionJun 8, 2026Failure to Fire

  AS REPORTED, THE SEALANT OF A 6-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) WAS NOT COMPLETELY UNSHEATHED FROM THE DEVICE. MILD DAMAGE WAS NOTED TO THE SEALANT SLEEVES AFTER REMOVAL. MANUAL COMPRESSION WAS HELD FOR HEMOSTASIS. THE DEVICE WAS USED WITH AN 8F SHEATH. THE OTHER TWO SITES IN THE LEFT GROIN WERE CLOSED SUCCESSFULLY. THE DEVICE WAS DISCARDED DURING CASE CLEAN UP. THE PROCEDURE USED A RETROGRADE APPROACH. THE DEPLOYER WAS TRAINED ON THE MYNX DEVICE. AN 8F AVANTI SHEATH INTRODUCER WAS USED. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. NO DAMAGE WAS NOTED TO THE BUTTON. THE BUTTON COMPLETELY DEPRESSED. THE TENSION INDICATOR WAS ALIGNED WITH THE MARKERS ON THE HANDLE HALVES BEFORE DEPLOYMENT. THE DEVICE STORAGE TEMPERATURE EXCEEDED 25 °C. NO KINKS WERE NOTED IN THE SHEATH OR DEVICE AFTER REMOVAL. THE TENSION INDICATOR DISPLAYED A CLOCK SYMBOL AFTER BUTTON #1 DEPRESSION. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430267 ↗
• MalfunctionJun 2, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THREE 6F¿12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICES (VCDS) WERE ASSOCIATED WITH CELLULITIS, SWELLING, REDNESS, AND PAINFUL GROINS AFTER FEMORAL VEIN CLOSURE. ONCE EACH MYNX DEVICE WAS DEPLOYED, PRESSURE WAS HELD FOR 2 MINUTES TO ACHIEVE HEMOSTASIS. THERE WAS A REPORTED PATIENT INJURY OF CELLULITIS, SWELLING, REDNESS, AND PAINFUL GROINS AFTER FEMORAL VEIN CLOSURE. THREE MYNX VENOUS VCDS WERE USED ON THE PATIENT, AND ALL WERE USED AT THE RIGHT FEMORAL VEIN. STERILE TECHNIQUE WAS FOLLOWED. THE PATIENT DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS PRIOR TO THE PROCEDURE. THE PATIENT WAS UNDER GENERAL ANESTHESIA, AND THE PROCEDURE WAS PERFORMED AS OUTPATIENT. THE ACCESS SITE WAS CLEANED WITH CHLORAPREP PRIOR TO DEPLOYMENT OF THE MYNX CONTROL VENOUS VCDS THROUGH THE SHEATHS. AFTER HEMOSTASIS WAS ACHIEVED, WET 4X4 GAUZE WAS USED TO CLEAN THE GROIN, AND A SMALL 4X4 DRESSING WITH TEGADERM WAS PLACED OVER THE SITE. 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). THE DEPLOYER WAS IN TRAINING WITH THE MYNX DEVICE. A 7F, 8F, AND 9F NON-CORDIS SHEATH WAS USED. FEMORAL ARTERY

  Patient problems: Unspecified Infection

  MAUDE report 25369157 ↗
• MalfunctionJun 1, 2026Premature Activation

  AS REPORTED, AFTER PASSING THE DISTAL TIP OF A 6F-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) THROUGH A NON-CORDIS SHEATH VALVE AND ADVANCING THE DEVICE PAST THE BALLOON, THE SEALANT SLEEVE SPLIT EXPOSING THE MYNX CONTROL VENOUS SEALANT. THE PHYSICIAN STOPPED ADVANCING THE DEVICE, RETRACTED THE DEVICE, AND COMPLETELY REMOVED THE DEVICE FROM THE SHEATH AND PATIENT WITHOUT ISSUE. THE PHYSICIAN THEN USED A DIFFERENT MYNX CONTROL VENOUS VCD TO SUCCESSFULLY CLOSE THE PATIENT¿S FEMORAL VENOUS ACCESS SITE. THERE WAS NO PATIENT HARM OR REPORTED PATIENT INJURIES. THE DEVICE WAS TO CLOSE THE PATIENT¿S FEMORAL VENOUS ACCESS SITE AFTER COMPLETION ON AN ABLATION PROCEDURE. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). A RETROGRADE APPROACH WAS UTILIZED DURING THE PROCEDURE, AND THE DEPLOYER WAS TRAINED ON THE MYNX DEVICE. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON VENOGRAPHY, INCLUDING THE APPROPRIATE INSERTION ANGLE OF THE VASCULAR SHEATH INTRODUCER, AND THE VESSEL DIAMETER WAS CONFIRMED TO BE GREATER THAN OR EQUAL TO 5 MM. THE DEVICE WAS REMOVED FROM THE PACKAGE BY HAVING THE CIRCULATING NURSE OPEN THE OUTER PACKAGE, AFTER WHICH THE SCRUB TECH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349637 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE POLYETHYLENE GLYCOL (PEG) MATERIAL OF A 6-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) WAS ASSOCIATED WITH BACKING OUT AT THE ACCESS SITE. THERE WAS A REPORTED PATIENT INJURY OF INFLAMMATION AND CELLULITIS REQUIRING ANTIBIOTIC TREATMENT. THE SITE WHERE THE DEVICE WAS USED APPEARED INFLAMED AND CELLULITIC, AND ANTIBIOTICS WERE ADMINISTERED WITH NO FURTHER TREATMENT REQUIRED. THE PATIENT RECOVERED AFTER THE MYNX EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE THE INCIDENT HAPPENED AT AN OFFICE FOLLOW-UP. STERILE TECHNIQUE WAS FOLLOWED. THE PATIENT DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS PRIOR TO THE PROCEDURE. THE PATIENT WAS UNDER ANESTHESIA DURING THE PROCEDURE, AND THE PROCEDURE WAS PERFORMED AS OUTPATIENT. THE ACCESS SITE WAS CLEANED AND MAINTAINED POST-PROCEDURE WITH CHLORAPREP. THE PATIENT WAS NOT IMMUNOCOMPROMISED AND HAD NOT EXPERIENCED A RECENT INFECTION. NO DAMAGES WERE FOUND ON THE DEVICE OR DEVICE PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE DEPLOYER WAS MYNX CERTIFIED. A CORDIS SHEATH INTRODUCER WAS USED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Local Reaction

  MAUDE report 25303168 ↗
• MalfunctionMay 17, 2026Premature Activation

  AS REPORTED, THE SEALANT OF A 6F¿12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) WAS HANGING OUTSIDE OF THE SLIT WHEN UNPACKAGED. THE CUSTOMER CHOSE TO USE A DIFFERENT DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE ISSUE WAS IDENTIFIED UPON OPENING THE PACKAGE. THE DEVICE WAS USED IN AN INTERVENTIONAL PROCEDURE, IT WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE, NO DAMAGE WAS NOTED TO THE BUTTON, THE DEVICE STORAGE TEMPERATURE DID NOT EXCEED 25 °C, NO KINKS WERE OBSERVED IN THE SHEATH OR DEVICE, NO DAMAGE WAS NOTED TO THE SEALANT SLEEVES. THE DEVICE WAS DISCARDED AT SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196694 ↗
• MalfunctionMay 8, 2026Therapy Delivered to Incorrect Body Area

  AS REPORTED, A 6F -12FMYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) CAME OUT WITH THE PEG STILL ATTACHED. THE PEG DID NOT FALL OUT OF THE MYNX VCD SHAFT UPON REMOVAL AND REMAINED ATTACHED, ALTHOUGH IT WAS FOUND OUTSIDE THE SHAFT. IT WAS REPORTED THAT BUTTON #2 WAS NOT DEPRESSED AS THE DEVICE WAS PULLED OUT BEFORE THAT STEP. HEMOSTASIS WAS ACHIEVED USING A SUTURE WITH STOP COCK. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS INSERTED INTO A 9F AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) AND THE DEPLOYMENT DIRECTIONS WERE FOLLOWED. THIS WAS DURING AN ATRIAL FIBRILLATION (AFIB) ABLATION. THE PATIENTS BODY MASS INDEX (BMI) WAS 44. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. THE DEVICE STORAGE TEMPERATURE DID NOT EXCEED 25 °C. THE PROCEDURE WAS PERFORMED USING AN ANTEGRADE APPROACH BY A DEPLOYER WHO WAS CERTIFIED ON THE MYNX DEVICE. FEMORAL VEIN SUITABILITY WAS VERIFIED ON VENOGRAPHY, INCLUDING CONFIRMATION OF THE APPROPRIATE 30¿45-DEGREE INSERTION ANGLE OF THE VASCULAR SHEATH INTRODUCER, AND VESSEL TORTUOSITY WAS DESCRIBED AS LITTLE. NO RESISTANCE WAS NOTED DURING USE OF THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125948 ↗
• MalfunctionMay 4, 2026Therapy Delivered to Incorrect Body Area

  AS REPORTED, THE PEG OF A 6F¿12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) DID NOT ADHERE TO THE VENOTOMY. THE SEALANT WAS NOT DEPLOYED AND REMAINED STUCK TO THE DEVICE. THE PEG CAME OUT AFTER PRESSING BUTTON 2 AND PULLING THE DEVICE OUT. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION FOR APPROXIMATELY 20 MINUTES. THERE WAS NO REPORTED PATIENT INJURY. DEVICE STORAGE TEMPERATURE DID NOT EXCEED 25 °C. THERE WAS NO SHALLOW VESSEL DEPTH REPORTED. BUTTON #1 AND BUTTON #2 WERE FULLY DEPRESSED, AND THE BALLOON WAS FULLY DEFLATED. NO RESISTANCE WAS NOTED DURING DEVICE USE. THE PROCEDURE WAS AN INTERVENTIONAL ELECTROPHYSIOLOGY ATRIAL FIBRILLATION ABLATION. THE USER WAS TRAINED IN THE DEVICE AT A PREVIOUS RESIDENCY PROGRAM. A NON-CORDIS SHEATH INTRODUCER WAS USED. THE VESSEL DIAMETER WAS REPORTED AS SUITABLE BUT NOT CONFIRMED. THE ACCESS SITE WAS THE RIGHT GROIN, WITH ONE ACCESS SITE OUT OF THREE AFFECTED WHILE TWO DEPLOYMENTS WERE SUCCESSFUL. SCAR TISSUE WAS NOTED IN THE VENOUS AREA FROM PREVIOUS PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068369 ↗
• MalfunctionMay 1, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A VASCULAR SURGEON REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH GROIN PAIN FOLLOWING A PRIOR ELECTROPHYSIOLOGY PROCEDURE (EP) WITH CLOSURE USING THREE 6F¿12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICES (VCD). ULTRASOUND SHOWED DEEP VEIN THROMBOSIS (DVT). IT WAS NOTED THAT THIS WAS THE ONLY INFORMATION AVAILABLE, AND THE LOCATION OF THE ORIGINAL ELECTROPHYSIOLOGY PROCEDURE WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25054072 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A VASCULAR SURGEON REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH GROIN PAIN FOLLOWING A PRIOR ELECTROPHYSIOLOGY PROCEDURE (EP) WITH CLOSURE USING THREE 6F¿12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICES (VCD). ULTRASOUND SHOWED DEEP VEIN THROMBOSIS (DVT). IT WAS NOTED THAT THIS WAS THE ONLY INFORMATION AVAILABLE, AND THE LOCATION OF THE ORIGINAL ELECTROPHYSIOLOGY PROCEDURE WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25053989 ↗
• MalfunctionApr 27, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED, BLEEDING OCCURRED FOLLOWING USE OF TWO 6F¿12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) AT LEFT FEMORAL VEIN ACCESS SITES (7F AND 11F). AVANTI+ 7F AND 11F SHEATHS WERE USED. THE PROCEDURE WAS AN ATRIAL FIBRILLATION PULSED FIELD ABLATION, AND THE DEVICE DEPLOYMENT WAS REPORTED AS SUCCESSFUL WITH NO ISSUES. THE PATIENT WAS NOTED TO HAVE DIFFICULT VASCULAR ACCESS. POST-PROCEDURE, THE PATIENT EXPERIENCED OOZING FROM BOTH LEFT AND RIGHT FEMORAL VEIN ACCESS SITES AS WELL AS INTRAVENOUS SITES AND WAS ADMITTED DUE TO CONTINUED/ EXCESSIVE BLEEDING. THE PATIENT WAS ON ANTIPLATELET THERAPY, AND BLEEDING CONTINUED THE FOLLOWING MORNING AFTER STITCH REMOVAL FROM A NON-CORDIS VASCULAR CLOSURE DEVICE SITE (RIGHT FEMORAL VEIN), REQUIRING ADDITIONAL BEDREST PRIOR TO DISCHARGE. THE PROCEDURE WAS PERFORMED USING A RETROGRADE APPROACH, AND THE DEPLOYER WAS MYNX CERTIFIED. VESSEL SUITABILITY WAS VERIFIED ON VENOGRAPHY, INCLUDING INSERTION ANGLE, AND VESSEL DIAMETER WAS CONFIRMED TO BE GREATER THAN OR EQUAL TO 5 MM. THERE WAS LITTLE VESSEL TORTUOSITY, AND PERIPHERAL VASCULAR DISEASE WAS NOTED WITH DIFFICULT ACCESS. THERE WAS NO PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25000136 ↗
• MalfunctionApr 24, 2026Premature Activation

  AS REPORTED, A 6-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) WOULD NOT PASS THE VALVE ON THE SHEATH AND WAS UNABLE TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE MYNX CONTROL VENOUS DEVICES HAVE BEEN REPORTED AS "SPLITTING" WHEN DELIVERED INTO THE SHEATH. MAINLY THE TUBING COVERING THE SEALANT IS SPLITTING TO THE POINT WHERE THE DEVICE IS NOT DELIVERABLE. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980526 ↗

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-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-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-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