Cordis ExoSeal Vascular Closure Device EX500Recalls & reported problems

Summary

The FDA's MAUDE database contains 500 adverse event reports that list this exact device (DI 10705032058872), received between Apr 9, 2020 and Sep 30, 2026 — classified as 3 injuries, 496 malfunctions.

The most frequently reported specific device problem is “Defective Component” (259 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, 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 500 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952471 ↗
• MalfunctionSep 30, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951201 ↗
• MalfunctionSep 29, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936947 ↗
• MalfunctionSep 29, 2026Defective Component

  As reported, the indicator window of a 5F Exoseal vascular closure device (VCD) could not change to black-black, so the device was withdrawn directly from the body. Hemostasis was achieved with manual compression. There was no reported patient injury. The operator used the device to close the puncture site. There were no visible signs of device or package damage prior to use. The device was stored and prepared according to the instructions for use (IFU). There was no difficulty connecting the vascular sheath introducer with the Exoseal VCD. The Indicator Wire Cowling locked against the Handle Assembly, and an audible click was heard. Pulsatile flow was observed from the Bleed-Back Indicator. The Exoseal VCD and vascular sheath introducer were retracted together until bleed-back significantly slowed or stopped. The physician did not have their thumb on the Plug Deployment Button during retraction. The Indicator Window did not show red during retraction. When the device was removed from the patient, the indicator wire loop was deployed/showing, and no anomalies were noted to the loop. Outside the patient's body, the guidewire loop required considerable force to make the Indicator Win

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936291 ↗
• MalfunctionSep 29, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936052 ↗
• MalfunctionSep 28, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923812 ↗
• MalfunctionSep 28, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923800 ↗
• MalfunctionSep 28, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923643 ↗
• MalfunctionSep 25, 2026Mechanical Jam

  As reported, the plug deployment button of a 5F Exoseal vascular closure device (VCD) could not be pressed. There was no reported patient injury. The device will be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892850 ↗
• MalfunctionSep 19, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831972 ↗
• MalfunctionSep 16, 2026Premature Activation; Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792457 ↗
• MalfunctionSep 16, 2026Defective Component

  As reported, the indicator windows of a 5F Exoseal vascular closure device (VCD) did not change color, and the plug did not deploy. Manual compression with gauze was used to achieve hemostasis. There was no reported patient injury. The device was stored and prepared according to the instructions for use. There was no difficulty connecting the 6F 2.0mm × 0.97mm .038-inch 11cm Avanti+ sheath introducer to the Exoseal VCD. The Indicator Wire Cowling locked against the Handle Assembly, and an audible click was heard. Pulsatile flow was observed from the Bleed-Back Indicator. The Exoseal VCD and sheath introducer were retracted together until bleed back significantly slowed or stopped. The indicator did not display black-black, and the Indicator Window did not show red during retraction. The physician did not have their thumb on the Plug Deployment Button during retraction. Femoral artery suitability was verified by angiography, including an insertion angle of 30-45 degrees, and the vessel diameter was verified to be at least 5 mm. There was no visible calcium or plaque, no access vessel tortuosity, no stent near the puncture site, and no stenosis greater than 50% at or near the punctur

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50783123 ↗
• MalfunctionSep 16, 2026Mechanical Jam

  As reported, the deployment button of a 5F Exoseal vascular closure device (VCD) could not be pressed, and the device could not be deployed. Manual compression was used for hemostasis. There was no reported patient injury. The procedure used a retrograde approach, and the physician was certified in the use of the Exoseal VCD. There were no visible signs of device or package damage before use. The device was stored and prepared according to the instructions for use (IFU). One Exoseal VCD and an unknown catheter sheath introducer were used for the patient. Angiography confirmed the suitability of the femoral artery and that the insertion angle of the vascular sheath introducer was 30¿45 degrees. The vessel diameter was confirmed to be greater than or equal to 5mm, and no obvious calcium deposition, plaque, stent, or stenosis greater than 50% was observed at or near the puncture site. Before use of the Exoseal VCD, there was no evidence of a pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site. The Exoseal VCD and vascular sheath introducer were retracted together until pulsatile flow from the Bleed-Back indicator significantly slowed or stopped and until

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50783109 ↗
• MalfunctionSep 15, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777819 ↗
• MalfunctionSep 15, 2026Mechanical Jam

  As reported, the button of a 5F Exoseal vascular closure device (VCD) could not be pressed during a carotid artery stent implantation procedure. The deployment button was reported as fully depressed and flush with the handle; however, it was also reported that excessive force was required and that the button only depressed halfway. Hemostasis was ultimately achieved using a suture-mediated closure device. There was no reported patient injury. The Exoseal vascular closure device (VCD) was stored, inspected, handled, and prepared according to the instructions for use (IFU), with no abnormalities noted prior to use. An antegrade approach was used, and femoral artery suitability was verified by angiography, including an appropriate insertion angle and a vessel diameter of at least 5 mm. No visible calcium/plaque, stent, or stenosis greater than 50% was reported at or near the puncture site. No resistance, excessive force, or difficulty connecting the VCD to the sheath introducer was reported. The sheath introducer engaged and locked with the handle assembly, an audible click was heard, and pulsatile flow was observed. The Indicator Window turned solid black. The device will be returned

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773886 ↗
• MalfunctionSep 15, 2026Failure to Fire

  As reported, part of the plug of a 5F Exoseal Vascular Closure Device (VCD) was pulled out and bleeding was observed at the puncture site when the device was removed. Manual compression was used to achieve hemostasis. There was no reported patient injury. There was no difficulty connecting the vascular sheath introducer with the Exoseal vascular closure device (VCD), no resistance or friction was experienced while advancing the Exoseal VCD through the sheath, and the sheath was not kinked or bent. The vascular sheath introducer was retracted until the hub engaged with the Indicator Wire Cowling and locked against the Handle Assembly. An audible click was heard, pulsatile flow was observed from the Bleed-Back Indicator, and the Deployment Button was fully depressed and flush against the handle. There was no issue with or damage to the deployment lever. The Exoseal VCD and vascular sheath introducer were removed as a single unit approximately 1¿2 seconds after depressing the Deployment Button, and the plug was brought out when the device was removed. The indicator wire was not visible when the device was removed. A non-Cordis catheter sheath introducer was used. Femoral artery suitab

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773742 ↗
• MalfunctionSep 15, 2026Mechanical Jam

  As reported, the plug deployment button of a 5F Exoseal vascular closure device (VCD) could not be pressed down after the indicator window changed to black-black. Hemostasis was achieved by manual compression. There was no reported patient injury. The operator was attempting to close the puncture site. There were no visible signs of device or package damage prior to use. The device was stored and prepared according to the instructions for use (IFU). The Exoseal VCD and vascular sheath introducer were retracted together until pulsatile flow from the Bleed-Back indicator significantly slowed or stopped and until the indicator window changed to solid black. When depression of the button was attempted, the button would not depress at all. The indicator window did not show any red color during retraction. The device was not attempted to be deployed outside the patient¿s body. A non-Cordis catheter sheath introducer was used. Femoral artery suitability was verified on angiography, including the vascular sheath introducer insertion angle of 30-45 degrees, and the vessel diameter was verified to be greater than or equal to 5 mm. There was no visible calcium or plaque at the puncture site,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766815 ↗
• MalfunctionSep 12, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50745089 ↗
• MalfunctionSep 11, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740019 ↗
• MalfunctionSep 11, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734203 ↗
• MalfunctionSep 9, 2026Mechanical Jam

  As reported, the deployment button of a 5F Exoseal vascular closure device (VCD) could not be pressed and therefore not be deployed. After removal from the patient, the plug had not detached from the Exoseal VCD device. Manual compression was used for hemostasis. There was no reported patient injury. The procedure used a retrograde approach. There were no visible signs of device or package damage before use. One Exoseal device was used for the patient. An unknown catheter sheath introducer was used. The device was stored and prepared per the instructions for use (IFU). The Exoseal VCD and vascular sheath introducer were retracted together until pulsatile flow from the Bleed-Back indicator significantly slowed or stopped and until the Indicator Window changed to solid black. The Indicator Window was solid black at the time of attempted button depression and did not show any red color during retraction. The device was not attempted to be deployed outside the patient¿s body. Angiography confirmed the suitability of the femoral artery, including confirmation that the insertion angle of the vascular sheath introducer was 30-45 degrees. The vessel diameter was confirmed to be greater tha

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50681561 ↗
• MalfunctionSep 8, 2026Difficult or Delayed Positioning

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50678936 ↗
• MalfunctionSep 8, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676399 ↗
• MalfunctionAug 25, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50432571 ↗
• MalfunctionAug 25, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50432230 ↗