Cordis ExoSeal Vascular Closure Device EX700Recalls & reported problems

Summary

The FDA's MAUDE database contains 402 adverse event reports that list this exact device (DI 10705032058896), received between Jul 17, 2019 and Sep 30, 2026 — classified as 7 injuries, 395 malfunctions.

The most frequently reported specific device problem is “Defective Component” (209 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 402 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 50952139 ↗
• MalfunctionSep 30, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951142 ↗
• MalfunctionSep 30, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948223 ↗
• MalfunctionSep 30, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947986 ↗
• MalfunctionSep 30, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947781 ↗
• MalfunctionSep 30, 2026Defective Component

  As reported, during withdrawal of a 7F Exoseal vascular closure device (VCD), the indicator window did not turn black at any point, even until the device was withdrawn from the patient¿s body. Manual compression was held for 13 minutes to complete the procedure. There were no reported injuries to the patient. The device was stored and prepared according to the instructions for use (IFU). The Exoseal vascular closure device (VCD) was used in an interventional procedure using a retrograde approach, and the physician had achieved certification for use of the Exoseal VCD. The patient¿s body mass index (BMI) was not greater than 40. There were no visible signs of device or package damage prior to use, and one Exoseal device was used. A 7F non-Cordis sheath was used. Femoral artery suitability was verified by angiography, including a 30¿45 degree insertion angle, and the vessel diameter was verified to be at least 5 mm. There was no visible calcium or plaque at the puncture site, no stent near the puncture site, no stenosis greater than 50% at or near the puncture site, no closure device or manual compression at the target femoral site within 30 days prior to the procedure, and no eviden

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947495 ↗
• MalfunctionSep 29, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933107 ↗
• MalfunctionSep 29, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932767 ↗
• MalfunctionSep 28, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926666 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926646 ↗
• MalfunctionSep 28, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923477 ↗
• MalfunctionSep 21, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847269 ↗
• MalfunctionSep 21, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846772 ↗
• MalfunctionSep 21, 2026Mechanical Jam

  As reported, the deployment button of a 7F Exoseal vascular closure device (VCD) could not be pressed, and the plug could not be released. After removal from the patient, the plug had not detached from the Exoseal VCD. Manual compression was used for hemostasis. There was no reported patient injury. A retrograde approach was used. There were no visible signs of device or package damage before use. 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. No stent was present near the puncture site. No resistance, excessive force, or difficulty connecting the VCD to the vascular sheath introducer was reported. The sheath introducer was retracted until its hub engaged with the Indicator Wire Cowling, locked against the Handle Assembly, and an audible click was heard. Agiography 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, with no obvious calcium deposition, plaque, stent, or stenosis greater than 50% observed at or ne

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842663 ↗
• MalfunctionSep 18, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831156 ↗
• MalfunctionSep 18, 2026Defective Component

  As reported, the indicator window of a 7F Exoseal vascular closure device (VCD) did not change color while the closure device was being used. There was no reported patient injury. Hemostasis was achieved by compression. 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. There was no difficulty connecting the unknown 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 unknown vascular sheath introducer were retracted together until bleed back significantly slowed or stopped. The indicator did not show a black-black state, and the Indicator Window did not show red during retraction. Deployment was attempted outside the patient¿s body and was difficult. Femoral artery suitability, including the vascular sheath introducer insertion angle of 30-45 degrees, was verified by angiography. There was no visible calcium or plaque at the puncture site, no access vessel tortuosity, no stent near the puncture site, and no stenosis greate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820315 ↗
• MalfunctionSep 17, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808978 ↗
• MalfunctionSep 16, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796720 ↗
• MalfunctionSep 16, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50783479 ↗
• MalfunctionSep 15, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777152 ↗
• MalfunctionSep 14, 2026Defective Component

  As reported, a 7F Exoseal Vascular Closure Device did not change color during withdrawal. The device was withdrawn from the body and 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). 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 indicator did not show black-black. 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/visible, and no anomalies were noted to the loop. The device was not attempted to be deployed outside the patient's body. Femoral artery suitability was verified on angiography, including the 30-45 degree insertion angle of the vascular sheath introducer. The vessel diameter was verified to be greater than or equal to 5

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50760848 ↗
• MalfunctionSep 11, 2026Premature Activation; Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50737505 ↗
• MalfunctionSep 10, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713365 ↗
• MalfunctionSep 9, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696787 ↗
• MalfunctionSep 9, 2026Defective Component

  As reported, the indicator window of a 7F Exoseal vascular closure device (VCD) did not change color at any point during withdrawal, even when the sheath tip was withdrawn outside the body, and closure failed. There was no reported patient injury. The device was used to close an 8F femoral artery sheath. The operating instructions were strictly followed, and the withdrawal angle was maintained during withdrawal of the sheath and closure device. During ex vivo testing, the guidewire loop required substantial pulling force, and the color-change response was insensitive. Hemostasis was achieved by compression. 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 vascular closure device (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 indicator did not show a black-black state

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50687070 ↗