Cordis ExoSeal Vascular Closure Device EX600Recalls & reported problems

Summary

The FDA's MAUDE database contains 377 adverse event reports that list this exact device (DI 10705032058858), received between Apr 17, 2019 and Sep 30, 2026 — classified as 1 death, 13 injuries, 363 malfunctions.

The most frequently reported specific device problem is “Defective Component” (191 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 377 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 50952351 ↗
• MalfunctionSep 30, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946187 ↗
• MalfunctionSep 29, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926736 ↗
• MalfunctionSep 28, 2026Defective Component

  As reported, while using a 6F Exoseal vascular closure device (VCD), closure was unsuccessful and hemostasis was not achieved. Pulsatile bleeding was noted 4 minutes after removal of the Exoseal VCD and sheath. Hemostasis was achieved by changing to another 6F Exoseal. 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 for an interventional procedure using a retrograde approach. The physician had achieved certification for use of the Exoseal VCD. No visible device or package damage was observed prior to use, and only one Exoseal device was used. The arterial site used a 6F non-Cordis sheath. Angiography confirmed the femoral artery was suitable for the procedure, including a vascular sheath insertion angle of 30¿45 degrees, and the vessel diameter was confirmed to be at least 5 mm. There was no visible calcium or plaque at the puncture site, no stent near the puncture site, and no stenosis greater than 50% at or near the puncture site. The target femoral site had not been previously closed with a closure device or manual compression within 30 days before t

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915221 ↗
• MalfunctionSep 23, 2026Defective Component

  As reported, the closure indicator window of the 6F Exoseal vascular closure device (VCD) did not change color. There was no reported injury to the patient. Additional information was requested; however, the information was not obtained after multiple attempts. The device will be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866954 ↗
• MalfunctionSep 23, 2026Mechanical Jam

  As reported, the plug deployment button of a 6F 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 50863313 ↗
• MalfunctionSep 16, 2026Defective Component

  As reported, the indicator windows of a 6F 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 50783202 ↗
• MalfunctionSep 15, 2026Mechanical Jam

  As reported, the deployment button of a 6F Exoseal Vascular Closure Device (VCD) could not be pressed. The button depressed only partially and was not able to be fully depressed. Hemostasis was achieved using a suture device. There was no reported patient injury. The Exoseal vascular closure device (VCD) and vascular sheath introducer were retracted together until pulsatile flow significantly slowed or stopped from the Bleed-Back indicator and until the Indicator Window changed to solid black. The Indicator Window was solid black at that time and did not show red during retraction. The device was not attempted to be deployed outside the patient's body. A non-Cordis 6F short sheath was used. The device was used for an interventional procedure and an antegrade approach was used. Femoral artery suitability, including the vascular sheath introducer insertion angle of 30-45 degrees, was verified by angiography, and the vessel diameter was verified to be at least 5 mm. There was no visible calcium or plaque, access vessel tortuosity, stent near the puncture site, or greater than 50% stenosis at or near the puncture site. The target femoral site had not been previously closed with a closu

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776626 ↗
• MalfunctionSep 9, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695654 ↗
• MalfunctionAug 24, 2026Therapy Delivered to Incorrect Body Area

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50419461 ↗
• MalfunctionAug 24, 2026Therapy Delivered to Incorrect Body Area

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50412686 ↗
• MalfunctionAug 17, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50276723 ↗
• MalfunctionAug 7, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50171890 ↗
• MalfunctionJul 27, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50038319 ↗
• MalfunctionJul 27, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50019535 ↗
• MalfunctionJun 2, 2026Failure to Fire

  AS REPORTED, THE SPONGE PLUG OF A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) COULD NOT DETACH FROM THE DEVICE AFTER DEPLOYMENT, RESULTING IN FAILURE TO CLOSE THE RIGHT FEMORAL ARTERY. MANUAL COMPRESSION AND AN ELASTIC BANDAGE WERE USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED FOLLOWING A CORONARY INTERVENTIONAL PROCEDURE FOR AN OCCLUSION OF THE LEFT CIRCUMFLEX ARTERY (LCX) AND THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE EVENT WAS REPORTED TO THE CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) AS A SERIOUS ADVERSE EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363571 ↗
• MalfunctionMay 26, 2026Defective Component

  AS REPORTED, WHEN OPERATING A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) THE MARKER DID NOT CHANGE, SO IT WAS RETRIEVED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25285089 ↗
• MalfunctionMay 25, 2026Failure to Fire

  AS REPORTED, THE PLUG OF A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) WAS PARTIALLY DEPLOYED, WITH HALF OF THE PLUG EXPOSED EXTERNALLY AND THE OTHER HALF REMAINING INSIDE THE DELIVERY ROD AFTER WITHDRAWAL. THE PLUG WAS REMOVED, AND A COMPRESSION DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED FOLLOWING A LOWER-LIMB ARTERIOSCLEROSIS OBLITERANS (ASO) PROCEDURE. HEMOSTASIS WAS ACHIEVED USING A COMPRESSION DEVICE, AND THE PROCEDURE WAS PERFORMED USING A RETROGRADE APPROACH IN AN INTERVENTIONAL PROCEDURE. THE VASCULAR SHEATH INTRODUCER WAS RETRACTED UNTIL THE HUB ENGAGED WITH THE INDICATOR WIRE COWLING AND LOCKED AGAINST THE HANDLE ASSEMBLY, WITH AN AUDIBLE CLICK HEARD. PULSATILE FLOW WAS OBSERVED FROM THE BLEED-BACK INDICATOR. THE DEPLOYMENT BUTTON WAS FULLY DEPRESSED. THE DEVICE AND SHEATH WERE REMOVED AS A SINGLE UNIT, AND THE PLUG DID NOT FALL OUT OF THE SHAFT. THE INDICATOR WIRE WAS NOT VISIBLE UPON REMOVAL. A NON-CORDIS CATHETER SHEATH INTRODUCER WAS USED. FEMORAL ARTERY SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, THE VESSEL DIAMETER WAS GREATER THAN OR EQUAL TO 5 MM, AND THERE WAS NO CALCIUM, PLAQUE, TORTUOSITY, STENT, OR STENOSIS GREAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25270437 ↗
• MalfunctionMay 12, 2026Failure to Fire

  AS REPORTED, THE PLUG OF A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) WAS NOT FULLY RELEASED AND THE CLOSURE WAS UNSUCCESSFUL. THERE WAS NO REPORTED PATIENT INJURY. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION. THERE WERE NO VISIBLE SIGNS OF DEVICE OR PACKAGE DAMAGE PRIOR TO USE, AND THE DEVICE WAS STORED AND PREPARED PER INSTRUCTIONS FOR USE (IFU). A NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) WAS USED. FOR THE PROCEDURE. THERE WERE NO DIFFICULTIES CONNECTING THE DEVICE OR ADVANCING IT THROUGH THE NON-CORDIS SHEATH, AND NO RESISTANCE OR SHEATH DEFORMATION WAS NOTED. THE VASCULAR SHEATH INTRODUCER WAS RETRACTED UNTIL THE HUB ENGAGED WITH THE INDICATOR WIRE COWLING AND WAS LOCKED WITH AN AUDIBLE CLICK. PULSATILE FLOW WAS OBSERVED, AND THE DEPLOYMENT BUTTON WAS FULLY DEPRESSED WITH NO ISSUE NOTED WITH THE DEPLOYMENT LEVER. THE DEVICE AND THE NON-CORDIS SHEATH WERE REMOVED AS A SINGLE UNIT, AND UPON REMOVAL, PART OF THE PLUG WAS PULLED OUT AND PARTIALLY FELL FROM THE SHAFT, AND THE INDICATOR WIRE WAS NOT VISIBLE. THE FEMORAL ARTERY WAS VERIFIED AS SUITABLE WITH APPROPRIATE ANGLE AND DIAMETER, WITH MILD PLAQUE, NO TORTUOSITY, NO NEARBY STENT, AND NO SIGNIFICANT STENOSIS. THERE WERE NO P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150912 ↗
• MalfunctionMay 12, 2026Failure to Fire

  AS REPORTED, THE INDICATOR WINDOW OF A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) TURNED BLACK; HOWEVER, HEMOSTASIS FAILED AND THE PLUG WAS NOT OBSERVED TO DEPLOY AFTER PRESSING THE DEPLOYMENT BUTTON. MANUAL COMPRESSION WAS PERFORMED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED VIA A RETROGRADE FEMORAL ARTERY APPROACH WITH A 40° WITHDRAWAL ANGLE, AND PULSATILE BLOOD FLOW HAD STOPPED PRIOR TO FURTHER WITHDRAWAL. THE DEVICE WAS WITHDRAWN AN ADDITIONAL 1 CM BEFORE DEPLOYMENT. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150728 ↗
• MalfunctionMay 11, 2026Mechanical Jam

  AS REPORTED, THE PLUG DEPLOYMENT BUTTON OF A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) COULD NOT BE PRESSED AFTER THE INDICATOR WINDOW CHANGED FROM BLACK- WHITE TO BLACK- BLACK. THE DEVICE WAS WITHDRAWN, AND MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. NO ABNORMALITY WAS NOTED PRIOR TO USE. THE INDICATOR WIRE LOOP DEPLOYED SMOOTHLY. THE SHEATH AND CLOSURE DEVICE WERE WITHDRAWN TOGETHER AT AN ANGLE OF 30¿45°. PULSATILE BLOOD FLOW WAS OBSERVED FROM THE BLEED-BACK PORT AND SLOWED SIGNIFICANTLY PRIOR TO FURTHER WITHDRAWAL. THE DEVICE WAS INSPECTED AFTER REMOVAL. PULLING THE INDICATOR WIRE LOOP CAUSED THE INDICATOR WINDOW TO CHANGE COLOR. PRESSING THE PLUG DEPLOYMENT BUTTON OUTSIDE THE BODY COULD NOT BE PERFORMED EASILY. THE PROCEDURE PERFORMED WAS INTRACRANIAL ANEURYSM EMBOLIZATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25138048 ↗
• MalfunctionMay 11, 2026Defective Component

  AS REPORTED, AFTER THE PROCEDURE, THE OPERATOR PERFORMED FEMORAL ARTERY CLOSURE WITH THE 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD). HOWEVER, THE INDICATOR WINDOW DID NOT CHANGE COLOR. MANUAL COMPRESSION WAS THEN USED INSTEAD. THE PATIENT WAS NOT INJURED. THE OPERATOR HAD BEEN TRAINED. NO ABNORMALITY WAS FOUND BEFORE USE. THE EXOSEAL VASCULAR CLOSURE DEVICE (VCD) WAS STORED, INSPECTED, HANDLED, AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO ABNORMALITIES WERE NOTED PRIOR TO USE. A RETROGRADE APPROACH WAS USED, AND ANGIOGRAPHY CONFIRMED FEMORAL ARTERY SUITABILITY, INCLUDING APPROPRIATE SHEATH INSERTION ANGLE. THE VESSEL DIAMETER WAS VERIFIED TO BE AT LEAST 5 MM AND NO CALCIUM, PLAQUE, STENT, OR SIGNIFICANT STENOSIS AT THE PUNCTURE SITE. A 6F NON-CORDIS SHEATH INTRODUCER WAS USED. NO RESISTANCE OR EXCESSIVE FORCE OCCURRED DURING ADVANCEMENT OR INSERTION, AND THERE WAS NO DIFFICULTY CONNECTING THE SHEATH INTRODUCER TO THE DEVICE. THE SHEATH ENGAGED AND LOCKED WITH THE INDICATOR WIRE COWLING WITH AN AUDIBLE CLICK, AND PULSATILE BLOOD FLOW WAS OBSERVED. ALTHOUGH RETRACTION WAS PERFORMED AS INSTRUCTED, THE INDICATOR WINDOW DID NOT DISPLAY A SOLID BLACK COLOR. THE DEVICE REMAI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25134936 ↗
• MalfunctionMay 8, 2026Defective Component

  AS REPORTED, AFTER THE PROCEDURE, THE OPERATOR PERFORMED FEMORAL ARTERY CLOSURE WITH THE 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD). HOWEVER, THE INDICATOR WINDOW DID NOT CHANGE COLOR. MANUAL COMPRESSION WAS THEN USED INSTEAD. THE PATIENT WAS NOT INJURED. THE OPERATOR HAD BEEN TRAINED. NO ABNORMALITY WAS FOUND BEFORE USE. THE EXOSEAL VASCULAR CLOSURE DEVICE (VCD) WAS STORED, INSPECTED, HANDLED, AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO ABNORMALITIES WERE NOTED PRIOR TO USE. A RETROGRADE APPROACH WAS USED, AND ANGIOGRAPHY CONFIRMED FEMORAL ARTERY SUITABILITY, INCLUDING APPROPRIATE SHEATH INSERTION ANGLE, WITH VESSEL DIAMETER VERIFIED TO BE AT LEAST 5 MM AND NO CALCIUM, PLAQUE, STENT, OR SIGNIFICANT STENOSIS AT THE PUNCTURE SITE. A 6F NON-CORDIS SHEATH INTRODUCER WAS USED. NO RESISTANCE OR EXCESSIVE FORCE OCCURRED DURING ADVANCEMENT OR INSERTION, AND THERE WAS NO DIFFICULTY CONNECTING THE SHEATH INTRODUCER TO THE DEVICE. THE SHEATH ENGAGED AND LOCKED WITH THE INDICATOR WIRE COWLING WITH AN AUDIBLE CLICK, AND PULSATILE BLOOD FLOW WAS OBSERVED. ALTHOUGH RETRACTION WAS PERFORMED AS INSTRUCTED, A SOLID BLACK INDICATION IN THE WINDOW WAS NOT OBSERVED. THE DEVICE REMAINED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129610 ↗
• MalfunctionMay 8, 2026Defective Component

  AS REPORTED, AFTER THE PROCEDURE, THE OPERATOR PERFORMED FEMORAL ARTERY CLOSURE WITH THE 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD). HOWEVER, THE INDICATOR WINDOW DID NOT CHANGE COLOR. MANUAL COMPRESSION WAS THEN USED INSTEAD. THE PATIENT WAS NOT INJURED. THE OPERATOR HAD BEEN TRAINED. NO ABNORMALITY WAS FOUND BEFORE USE. THE EXOSEAL VASCULAR CLOSURE DEVICE (VCD) WAS STORED, INSPECTED, HANDLED, AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO ABNORMALITIES WERE NOTED PRIOR TO USE. A RETROGRADE APPROACH WAS USED, AND ANGIOGRAPHY CONFIRMED FEMORAL ARTERY SUITABILITY, INCLUDING APPROPRIATE SHEATH INSERTION ANGLE, WITH VESSEL DIAMETER VERIFIED TO BE AT LEAST 5 MM AND NO CALCIUM, PLAQUE, STENT, OR SIGNIFICANT STENOSIS AT THE PUNCTURE SITE. A 6F NON-CORDIS SHEATH INTRODUCER OF UNKNOWN MODEL WAS USED. NO RESISTANCE OR EXCESSIVE FORCE OCCURRED DURING ADVANCEMENT OR INSERTION, AND THERE WAS NO DIFFICULTY CONNECTING THE SHEATH INTRODUCER TO THE DEVICE. THE SHEATH ENGAGED AND LOCKED WITH THE INDICATOR WIRE COWLING WITH AN AUDIBLE CLICK, AND PULSATILE BLOOD FLOW WAS OBSERVED. ALTHOUGH RETRACTION WAS PERFORMED AS INSTRUCTED, A SOLID BLACK INDICATION IN THE WINDOW WAS NOT OBSERVED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128998 ↗
• MalfunctionMay 8, 2026Defective Component

  AS REPORTED, DURING USE OF A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) THE INDICATOR WINDOW DID NOT CHANGE COLOR. 3 TO 4 MINUTES OF MANUAL COMPRESSION WAS THEN USED INSTEAD. THERE WERE NO REPORTED INJURIES TO THE PATIENT OR SIGNS OF INFECTIOUS DISEASE. THE DEVICE WAS BEING USED FOR FEMORAL ARTERY CLOSURE. THE OPERATOR HAD BEEN TRAINED TO THE DEVICE. NO ABNORMALITIES WERE FOUND BEFORE USE. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE PROCEDURE USED A RETROGRADE APPROACH, AND EXOSEAL VASCULAR CLOSURE DEVICE (VCD) WAS USED IN AN INTERVENTIONAL PROCEDURE. ONE EXOSEAL DEVICE WAS USED WITH A NON-CORDIS SHEATH. ANGIOGRAPHY CONFIRMED FEMORAL ARTERY SUITABILITY, INCLUDING APPROPRIATE 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 NEARBY STENT, NO STENOSIS GREATER THAN 50% AT OR NEAR THE PUNCTURE SITE, NO PRIOR CLOSURE DEVICE USE OR MANUAL COMPRESSION AT THE TARGET FEMORAL SITE WITHIN 30 DAYS, AND NO EVIDENCE OF PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDOANEURYSM AT THE ACCESS SITE BEFORE EXOSEAL VCD USE. THERE WAS NO DIFFICULTY CONNECTING THE NON-CORD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125440 ↗