ANGIO-SEAL 610131Recalls & reported problems

Summary

The FDA's MAUDE database contains 413 adverse event reports that list this exact device (DI 00389701011813), received between Jan 15, 2018 and Sep 29, 2026 — classified as 1 death, 229 injuries, 183 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (74 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 413 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Activation Problem

  Terumo Medical Corporation received the following information: It was reported that the physician got femoral access and removed the clot. When the physician tried to close with Angio-Seal it was discovered that the anchor was not deployed. According to the staff, the Angio-Seal device was inserted through the Angio-Seal sheath and clicked into place. When the device was pulled back to position the anchor against the sheath it was clear that the anchor was not deployed outside of the sheath. The device was removed and manual pressure was performed to achieve hemostasis and close. The case was completed successfully. The procedure was a stroke case.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927481 ↗
• MalfunctionSep 23, 2026Activation Problem

  Terumo received the following reported information: The doctor did the location of blood with dilator and put the device in. When he went to pull back nothing hooked or came out. The device slid out of the Arteriotomy. When inspected the account stated the footplate and collagen were still in the sheath. There was no harm to the patient; however, manual pressure was held. The procedure performed was a Carotid Angiogram. No blood loss was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870951 ↗
• MalfunctionSep 22, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862509 ↗
• MalfunctionSep 18, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50827123 ↗
• InjurySep 17, 2026Migration

  Terumo Medical Corporation received the following information: It was reported that upon deploying the 8Fr Angio-Seal, the device failed causing the patient to get a cold leg and lose pulses. Angio from the other side showed the common femoral artery (CFA) was occluded where device was deployed. The Physician stated that the vessel was quite calcified and likely not a great spot to use Angio-Seal, however, was his only option. Vessel was noticeable diseased. Attempts were made to balloon the Angio-Seal occlusion from the contralateral side and ultimately vascular surgery was performed to place a Zilver stent in the common femoral artery (CFA). Extended manual pressure was used to control bleeding. The patient remained in stable condition. The estimated blood loss was less than 250cc. An 8Fr procedure size sheath was used. This was a tough stick. No reported issues with insertion, deployment, or withdrawal of the device. A pre-deployment angiogram was performed, and it showed disease. Site was at or just below the common femoral artery bifurcation. Doplar gave initial concern. Angio eventually performed to show distal pulses were absent initially, however, fully restored following i

  Patient problems: Diminished Pulse Pressure; Obstruction/Occlusion

  MAUDE report 50797583 ↗
• MalfunctionSep 9, 2026Activation Problem

  Terumo received the following reported information: When attempting to deploy the footplate did not deploy properly, it remained within the artery and did not retract from the sheath as intended. The patient underwent an EPS procedure for PVCs prior to closure device deployment. An 8 French procedure sheath was used. There were no difficulties with arterial access, and ultrasound guidance was utilized for access. A pre-deployment angiogram was performed. Following the procedure, the physician held manual pressure at the access site to achieve hemostasis. Estimated blood loss was very minimal, if any. The patient was stable following the procedure. A vascular physician was also called in for consultation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690252 ↗
• MalfunctionAug 14, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254843 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hematoma

  MAUDE report 50224292 ↗
• MalfunctionJun 26, 2026

  ANGIO-SEAL CLOSURE DEVICE FAILED TO DEPLOY AFTER PCI. PATIENT WAS HEPARINIZED AND HAD SMALL HEMATOMA INITIALLY, MANUAL PRESSURE HELD FOR 45 MINS.

  Patient problems: Hematoma

  MAUDE report 25634336 ↗
• MalfunctionMay 20, 2026Activation Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT WHEN SETTING THE ANCHOR AND PULLING BACK FOR DEPLOYMENT, THERE WAS NO SUTURE OR COMPONENTS VISIBLE. THEY LOST ACCESS AND HAD TO HOLD MANUAL PRESSURE. THERE WAS NO BLOOD LOSS. IT WAS CONFIRMED THAT THE ANCHOR WAS STILL IN THE DEVICE. TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5187554. THE EVENT DESCRIPTION STATES: "CLOSURE UNSUCCESSFUL DUE TO ANGIOSEAL COLLAGEN PLUG AND WIRE DEFECTED DURING ATTEMPTED DEPLOYMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25236263 ↗
• MalfunctionMay 5, 2026Activation Problem

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PROCEDURE PERFORMED WAS A LEFT ILLIAC ARTERY INTERVENTION WITH RIGHT COMMON FEMORAL ARTERY (CFA) ACCESS. WHEN THE DOCTOR DEPLOYED THE ANGIO-SEAL HE STATED ''THERE WAS NO PLUG.'' THEY ENDED UP HOLDING MANUAL PRESSURE AND NOT USING A SECOND DEVICE. THERE WAS NO INJURY REPORTED AND THE PATIENT WAS DOING GREAT. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. THE PATIENT'S ABI'S WERE GOOD. NO BLOOD LOSS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084254 ↗
• MalfunctionMay 4, 2026Activation Problem

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION AFTER THE TECH SUCCESSFULLY INSERTED THE DILATOR/SHEATH AND THEN INSERTED DEVICE AND SUCCESSFULLY LOCKED FORWARD/BACKWARDS AND WENT TO PULL TENSION OUT. THE DEVICE WAS LOCKED AND WOULD NOT RELEASE OR ALLOW STRING DEPLOYMENT. THE TECH CUT ABOVE CONNECTION POINT AND WAS ABLE TO GRAB STRING/TAMP AND ACHIEVE HEMOSTASIS. THE PATIENT WAS STABLE, AND NO BLOOD LOSS WAS REPORTED. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE PROCEDURE PERFORMED WAS A CORONARY PCI. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. THE PROCEDURE SHEATH SIZE USED WAS AN 8 FRENCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071128 ↗
• MalfunctionApr 24, 2026Activation Failure

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE TYPE OF PROCEDURE PERFORMED WAS SMA ANEURYSM EMBOLIZATION/ BILATERAL COMMON ILIAC STENTING FROM FEMORAL APPROACH VIA 7 FRENCH PINNACLE SHEATH. THE DEVICE DID NOT SEAL. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION NOTED BY THE DOCTOR. THERE WAS A PRE-DEPLOYMENT ANGIOGRAM PERFORMED. THE DOCTOR BELIEVED EVERYTHING WENT SMOOTH. HE SAID WHEN HE PULLED BACK, HE DID NOT THINK THE ANKUR ENGAGED AND EVERYTHING CAME OUT. HE SAID HE COULD SEE THE ANCHOR IN THE DEVICE STILL. HEMOSTASIS WAS ACHIEVED BY MANUAL PRESSURE. THE DOCTOR ESTIMATED THE BLOOD LOSS WAS 10 CC. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982360 ↗
• MalfunctionApr 13, 2026Activation Failure

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE ANGIO-SEAL DEVICE DID NOT APPEAR TO HAVE A SUTURE OR COLLAGEN IN IT. THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860691 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A NEURO INTERVENTION FOR STROKE VIA 8 FRENCH SHEATH THE 8 FRENCH ANGIO-SEAL WAS USED TO CLOSE THE PATIENT'S RIGHT GROIN. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED AND ACCORDING TO THE TECH IT LOOKED CLEAN. ACCORDING TO THE STAFF, THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. THE DEVICE APPEARED TO NOT FUNCTION AND HEMOSTASIS WAS NOT ACHIEVED. THE DOCTOR AND TECH HELD PRESSURE UNTIL HEMOSTASIS WAS ACHIEVED. A DOPPLER WAS PERFORMED ON THE RIGHT FOOT AND SIGNALS WERE ACHIEVED ON THE RIGHT FOOT. THERE WAS NO HEMATOMA ON THE RIGHT GROIN. LATER THAT DAY (3:16 AM) THE STAFF WAS NOTIFIED THAT THE PATIENT HAD TO GO TO OPERATING ROOM (OR) FOR A CUT DOWN ON THE RIGHT FEMORAL ARTERY AND THE COLLAGEN WAS REMOVED. THE BLOOD LOSS WAS LESS THAN 250CC, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851839 ↗
• MalfunctionApr 10, 2026Activation Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A FEMORAL INTERVENTION VIA 8 FRENCH SHEATH, THE ANGIO-SEAL WAS ATTEMPTED TO BE USED. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THERE WERE NOT ANY ISSUES WITH INSERTION, DEPLOYMENT, OR WITHDRAWAL OF THE DEVICE. THERE WAS BAD PULSATION FLOW; THEREFORE, WHEN THEY ATTEMPTED TO ADVANCE THE PLUG, IT WOULD NOT ADVANCE HALFWAY THROUGH THE SHEATH. MANUAL PRESSURE WAS HELD AND THE PATIENT WAS STABLE. BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844503 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A NEURO INTERVENTION FOR STROKE VIA 8 FRENCH SHEATH THE 8 FRENCH ANGIO-SEAL WAS USED TO CLOSE THE PATIENT'S RIGHT GROIN. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED AND ACCORDING TO THE TECH IT LOOKED CLEAN. ACCORDING TO THE STAFF, THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. THE DEVICE APPEARED TO NOT FUNCTION AND HEMOSTASIS WAS NOT ACHIEVED. THE DOCTOR AND TECH HELD PRESSURE UNTIL HEMOSTASIS WAS ACHIEVED. A DOPPLER WAS PERFORMED ON THE RIGHT FOOT AND SIGNALS WERE ACHIEVED ON THE RIGHT FOOT. THERE WAS NO HEMATOMA ON THE RIGHT GROIN. LATER THAT DAY (3:16 AM) THE STAFF WAS NOTIFIED THAT THE PATIENT HAD TO GO TO OPERATING ROOM (OR) FOR A CUT DOWN ON THE RIGHT FEMORAL ARTERY AND THE COLLAGEN WAS REMOVED. THE BLOOD LOSS WAS LESS THAN 250CC, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844383 ↗
• MalfunctionMar 26, 2026Difficult to Remove; Activation, Positioning or Separation Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT WHEN DEPLOYING THE ANGIO-SEAL THE DOCTOR COULD NOT PULL BACK ON THE DEVICE AFTER DEPLOYING THE FOOTPLATE. DOCTOR CUT THE CARRIER TUBE AND PULLED THE SHEATH OFF EXPOSING THE SUTURE. SHE THEN PULLED BACK ON THE SUTURE AND TAMPED WITH THE TAMPER, FINISHED THE DEPLOYMENT WITH NO OTHER ISSUES. A 7FR. PROCEDURE SHEATH WAS USED. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THERE WERE NO ISSUES OR DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. THERE PATIENT HAD A PERIPHERAL PROCEDURE. THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698907 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE PATIENT ARRIVED IN THE EMERGENCY ROOM WITH A COLD LEG ON (B)(6) 2026. AN AORTA WITH BILATERAL LOWER LEG ANGIOGRAM WAS PERFORMED. LEFT GROIN ACCESS WAS CHOSEN BECAUSE OF RIGHT LEG BEING SYMPTOMATIC. A 4FR MICROPUNCTURE KIT WAS USED TO GAIN ACCESS AND A 5 FR X 10CM PINNACLE SHEATH WAS INSERTED. AN ANGIOGRAM WAS PERFORMED AND IT WAS DETERMINED THE PATIENT NEEDED THROMBOLYSIS. THE 5FR SHEATH WAS REPLACED WITH AN 8FR X 45CM DESTINATION SHEATH. THROMBOLYSIS WAS PERFORMED WITH THE INARI SYSTEM. UPON COMPLETING THROMBOLYSIS, A LEFT GROIN ANGIOGRAM WAS PERFORMED AND AN 8FR ANGIO-SEAL VIP WAS SUCCESSFULLY DEPLOYED WITHOUT INCIDENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2026, IN STABLE CONDITION. THE PATIENT ARRIVED IN THE EMERGENCY ROOM AGAIN ON (B)(6) 2026, WITH A HARD LEFT SIDED GROIN. WHEN ULTRASOUND WAS PERFORMED, A PSEUDOANEURYSM WAS SEEN OVER THE SITE OF THE ANGIO-SEAL DEPLOYMENT. ULTRASOUND PICTURE WAS OBTAINED. THROMBIN WAS INJECTED INTO THE SAC OF THE ANEURYSM, THE BLEEDING STOPPED AND THE PATIENT WAS SENT HOME IN STABLE CONDITION.

  Patient problems: Pseudoaneurysm

  MAUDE report 24678430 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT ON (B)(6) 2026 THE DOCTOR INSERTED AN ANGIO-SEAL INTO THE PATIENT. ON (B)(6) 2026 WHILE STILL IN THE HOSPTIAL THE PATIENT DEVELOPED A LARGE HEMATOMA AND PSEUDOANEURYSM. THE PATIENT WAS NOT AMBULATING. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Hematoma; Pseudoaneurysm

  MAUDE report 24635681 ↗
• MalfunctionMar 17, 2026Activation Failure

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A CAROTID STENT VIA 8 FRENCH SHEATH, THE ANGIO-SEAL WAS ATTEMPTED TO CLOSE THE LEFT GROIN. HOWEVER, THE DEVICE DID NOT ACHIEVE HOMEOSTASIS AT WITHDRAWAL. THEREFORE, MANUAL PRESSURE WAS APPLIED WAS A FEMSTOP WAS USED. THE STAFF TRANSFERRED THE PATIENT WAS THE PROCEDURE TABLE TO A STRETCHER WHILE HOLDING PRESSURE. A STAFF MEMBER HELD MANUAL PRESSURE AND NEEDED TO BE SWITCHED OUT MULTIPLE TIMES. THE PATIENT WAS WHEELED OUT TO POST-OP WHILE STAFF MEMBER HELD PRESSURE. HEMOSTASIS SHOULD HAVE BEEN ACHIEVED PRIOR TO MOVING THE PATIENT. THE PATIENT WAS STABLE, AND THE BLOOD LOSS WAS LESS THAN 250CC. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. NO EQUIPMENT OR OTHER DEVICES WERE USED WITH THE ANGIO-SEAL. THE PATIENT WAS ON HEPRIN, PLAVIX, BRILINTA; HOWEVER, DID NOT HAVE A HISTORY OF A BLEEDING DISORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619052 ↗
• MalfunctionMar 17, 2026

  WHEN THE ANGIOSEAL DEPLOYED IN PATIENT SURGEON FOUND DEVICE HAD DEPLOYED PRIOR TO USE. DEVICE UNABLE TO BE DEPLOYED IN PATIENT BECAUSE ALREADY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616356 ↗
• InjuryMar 13, 2026Activation Failure

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE DOCTOR USED AN 8FR ANGIO-SEAL TO CLOSE THE COMMON FEMORAL ARTERY. WHEN THE DOCTOR WENT TO PULL EVERYTHING BACK TO DEPLOY THE COLLOGEN THE FOOT PLATE DID NOT COME OUT OF THE SHEATH. EVERYTHING CAME OUT OF THE PATIENT'S BODY. THE DOCTOR LEFT A WIRE FOR ACCESS BACK UP WHEN DEPLOYING THE FIRST ANGIO-SEAL DEVICE. A SECOND 8FR ANGIO-SEAL WAS USED, WHEN PULLING BACK TO DEPLOY THE COLLAGEN EVERYTHING CAME OUT OF THE BODY, THE FOOTPLATE DID NOT DEPLOY. HEMOSTASIS WAS ACHIEVED BY HOLDING PRESSURE AND PERFORMING A SURGICAL CUT DOWN ON COMMON FEMORAL ARTERY. A PRE-DEPLOYMENT ANGIOGRAM WAS NOT PERFORMED. THERE WERE NO ISSUES NOTED REGARDING DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION WITH EITHER ANGIO-SEAL DEVICE. THERE WAS NO PATIENT HARM AND THE PATIENT REMAINED STABLE. TYPE OF PROCEDURE PERFORMED PRIOR TO THE USE OF ANGIO-SEAL WAS A PERIPHERAL INTERVENTION. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598375 ↗
• MalfunctionMar 13, 2026Activation Failure

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE DOCTOR USED AN 8FR ANGIO-SEAL TO CLOSE THE COMMON FEMORAL ARTERY. WHEN THE DOCTOR WENT TO PULL EVERYTHING BACK TO DEPLOY THE COLLOGEN THE FOOT PLATE DID NOT COME OUT OF THE SHEATH. EVERYTHING CAME OUT OF THE PATIENT'S BODY. THE DOCTOR LEFT A WIRE FOR ACCESS BACK UP WHEN DEPLOYING THE FIRST ANGIO-SEAL DEVICE. A SECOND 8FR ANGIO-SEAL WAS USED, WHEN PULLING BACK TO DEPLOY THE COLLAGEN EVERYTHING CAME OUT OF THE BODY, THE FOOTPLATE DID NOT DEPLOY. HEMOSTASIS WAS ACHIEVED BY HOLDING PRESSURE AND PERFORMING A SURGICAL CUT DOWN ON COMMON FEMORAL ARTERY. A PRE-DEPLOYMENT ANGIOGRAM WAS NOT PERFORMED. THERE WERE NO ISSUES NOTED REGARDING DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION WITH EITHER ANGIO-SEAL DEVICE. THERE WAS NO PATIENT HARM AND THE PATIENT REMAINED STABLE. TYPE OF PROCEDURE PERFORMED PRIOR TO THE USE OF ANGIO-SEAL WAS A PERIPHERAL INTERVENTION. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594857 ↗
• MalfunctionMar 6, 2026Activation Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT DURING THE CLOSURE OF AN 8FR FEMORAL ACCESS PROCEDURE THE 8FR ANGIO-SEAL HAD AN ISSUE DURING DEPLOYMENT AND MAY NOT HAVE MADE A FULL SECOND CLICK DURING DEPLOYMENT. THE PROCEDURE PRIOR TO THE USE OF THE ANGIO-SEAL DEVICE WAS FEMORAL ACCESS NEUROVASCULAR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537009 ↗