MYNX CONTROLRecalls & reported problems across all models

We found 2 models of MYNX CONTROL by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 534 adverse event reports in the FDA's MAUDE database, received between Feb 12, 2019 and Sep 29, 2026 — classified as 3 deaths, 55 injuries, 476 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (196 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MYNX CONTROL problems

MYNX CONTROL models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MYNX CONTROL MX6760

  Device, hemostasis, vascular
  2 deaths280 reports
• MYNX CONTROL MX5060

  Device, hemostasis, vascular
  1 death254 reports

Recent MYNX CONTROL adverse event reports

The 15 most recent reports across all models, 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 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, 2026Decrease in Pressure; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794142 ↗
• 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 ↗
• MalfunctionSep 16, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50786952 ↗
• 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692439 ↗
• 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 ↗

Other Cordis US Corp. products

• MYNXGRIP2 models · 2,276 reports · 2 recalls
• Cordis ExoSeal Vascular Closure Device3 models · 1,279 reports
• POWERFLEX56 models · 306 reports
• SABER51 models · 270 reports
• Cordis S.M.A.R.T. Control Vascular Stent System30 models · 99 reports · 2 recalls
• INFINITI20 models · 107 reports
• AVIATOR19 models · 75 reports
• AVANTI11 models · 70 reports