Cordis ExoSeal Vascular Closure DeviceRecalls & reported problems across all models

We found 3 models of Cordis ExoSeal Vascular Closure Device by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 1,279 adverse event reports in the FDA's MAUDE database, received between Apr 17, 2019 and Sep 30, 2026 — classified as 1 death, 23 injuries, 1,254 malfunctions.

The most frequently reported specific device problem is “Defective Component” (659 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 Cordis ExoSeal Vascular Closure Device problems

Cordis ExoSeal Vascular Closure Device models

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

• Cordis ExoSeal Vascular Closure Device EX500

  DEVICE, HEMOSTASIS, VASCULAR
  500 reports
• Cordis ExoSeal Vascular Closure Device EX700

  DEVICE, HEMOSTASIS, VASCULAR
  402 reports
• Cordis ExoSeal Vascular Closure Device EX600

  DEVICE, HEMOSTASIS, VASCULAR
  1 death377 reports

Recent Cordis ExoSeal Vascular Closure Device adverse event reports

The 15 most recent reports across all models, 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, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952351 ↗
• MalfunctionSep 30, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952139 ↗
• MalfunctionSep 30, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951201 ↗
• 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 30, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946187 ↗
• 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 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 ↗

Other Cordis US Corp. products

• MYNXGRIP2 models · 2,276 reports · 2 recalls
• MYNX CONTROL2 models · 534 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