ANGIO-SEAL 610130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,651 adverse event reports that list this exact device (DI 00389701011820), received between Aug 7, 2017 and Sep 29, 2026 — classified as 3 deaths, 1,037 injuries, 611 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (443 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,651 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933596 ↗
• MalfunctionSep 24, 2026Activation Problem

  Terumo received the following reported information: Following a Left Heart Cath via 6 French sheath, the Angio-Seal did not deploy. No blood loss was reported. There were no reported difficulties with arterial access, sheath placement, guidewire advancement, or catheter insertion. A pre-deployment angiogram was performed. There were no reported issues with insertion, deployment, or withdrawal of the device. Hemostasis was achieved using manual pressure. The patient was stable. No concomitant medical products were used with the Angio-Seal.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883743 ↗
• MalfunctionSep 24, 2026Activation Failure

  Terumo Medical Corporation received the following information: It was reported that the Angio-Seal was being used on the patient. When they got to the pull back step and whole Angio-Seal pulled out of the patient. The anchor never came out of the tip of the sheath. Manual pressure was applied. The patient was ok. The doctor cut open the sheath to visualize, the anchor was stuck in the sheath.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882882 ↗
• MalfunctionSep 24, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882408 ↗
• MalfunctionSep 23, 2026Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873653 ↗
• MalfunctionSep 23, 2026Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872486 ↗
• MalfunctionSep 22, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862366 ↗
• MalfunctionSep 18, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829567 ↗
• MalfunctionSep 18, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50823415 ↗
• MalfunctionSep 18, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50822283 ↗
• MalfunctionSep 18, 2026Activation Failure

  Terumo Medical Corporation received the following information: It was reported that an Angio-Seal was placed however it would not deploy, therefore pressure was held. The estimated blood loss was less than 250cc. Procedure performed was bleed. A 6fr procedure size sheath was used. There were no difficulties with arterial access, sheath, guidewire, or catheter insertion. Device did not deploy, appeared to jam at the end. A pre-deployment angiogram was not performed. Patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813271 ↗
• MalfunctionSep 17, 2026Activation Problem

  Terumo received the following reported information: The anchor plate did not deploy from the sheath causing the entire device to be removed and pressure was held. The procedure performed was a Peripheral Intervention via 6 French sheath. It was unknown if there were difficulties with arterial access, sheath, guidewire, or catheter insertion. It was unknown if there were any issues with insertion, deployment, or withdrawal of the device. A pre-deployment angiogram was performed. The patient was stable, and the blood loss was less than 250cc.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804053 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Terumo Medical Corporation received the following information: It was reported that an Angio-Seal device was used on the patient and had to be hospitalized later with a grapefruit size hematoma and potentially a pseudoaneurysm. The procedure and Angio-Seal insertion occurred on (b)(6), 2026. On (b)(6), 2026, the patient was transported to the hospital after walking and feeling a pop at the access site, followed by severe pain and swelling approximately the size of a grapefruit. The patient was admitted for application of a pressure dressing and consultation with vascular surgery. Prior to closure with the Angio-Seal device, the patient underwent a prostatic artery embolization (PAE) procedure. No difficulties were noted with arterial access, sheath placement, guidewire, or catheter insertion in the operative note. A pre-deployment angiogram was not confirmed. Computed tomography (CT) images from the PAE procedure. No difficulties were documented in the operative note regarding insertion, deployment, or withdrawal of the device. The patient was hospitalized overnight and required a pressure bandage and vascular surgery consultation. At this time, no further surgical intervention is

  Patient problems: Hematoma; Pain; Swelling/ Edema

  MAUDE report 50716634 ↗
• MalfunctionSep 10, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50715931 ↗
• MalfunctionSep 10, 2026Activation Problem

  Terumo Medical Corporation received the following information: It was reported that arterial access was obtained and the procedure was successfully completed. Upon deployment of the Angio-Seal, the delivery piece would not release. Physician was finally able to remove the delivery system, and the device was used successfully. The patient was doing fine and was stable. The estimated blood loss was less than 250cc.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714808 ↗
• InjurySep 8, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Terumo received the following reported information: The Angio-Seal was placed in the patient's right femoral artery. However, the patient lost pulse in that leg. Surgical repair was required to remove the plug and restore blood flow.

  Patient problems: Obstruction/Occlusion

  MAUDE report 50671669 ↗
• MalfunctionSep 8, 2026Break; Material Deformation; Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671627 ↗
• MalfunctionAug 31, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50520833 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Foreign Body Embolism; Obstruction/Occlusion

  MAUDE report 50419465 ↗
• MalfunctionAug 24, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410544 ↗
• MalfunctionAug 24, 2026Loose or Intermittent Connection

  Terumo received the following reported information: Following a Peripheral Procedure, the doctor attempted to use the Angio-Seal by placing the bypass tube through the valve after locating the artery. Three devices were attempted; however, they did not function properly. However, a fourth device was used successfully. No blood loss was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50408777 ↗
• MalfunctionAug 19, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325676 ↗
• InjuryAug 14, 2026Activation Failure

  Terumo Medical Corporation received the following information: It was reported that upon deployment, the Angio-seal footplate did not properly deploy. When asked if all proper steps were taken, the doctorh stated that they were. The bypass tube was inserted into the sheath and advanced. They stated that the first click was done and a second click as well. When they went to pull back after the second click, the entire device came out of the patient. Once this happened, the team scrubbed in performed manual pressure to get hemostasis. The patient was reported to be ok as well. A 6fr sheath was used. No difficulties with access or any introductions through the sheath. A pre-deployment angiogram was performed. The estimated blood loss was greater than 250cc. The procedure performed prior to the use of the Angio-Seal was Y-90.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50246575 ↗
• MalfunctionJun 25, 2026Difficult to Insert

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE 6 FRENCH ANGIO-SEAL SHEATH AND DILATOR COULD NOT ENTER THE COMMON FEMORAL ARTERY (CFA). A 6 FRENCH SHEATH WAS USED FOR THE INTERVENTION. THE ANATOMY WAS NOT TORTUOUS, LARGER THAN 5MM CFA, AND NO CALCIUM. A PERCLOSE WAS USED AFTER ATTEMPTED USE OF THE ANGIO-SEAL AND NOTHING WORKED. THE PATIENT ENDED UP HAVING A PSEUDOANEURYSM; HOWEVER, THE PATIENT LEFT UNHARMED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WERE NOT ANY DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. THERE WAS A PRE-DEPLOYMENT ANGIOGRAM PERFORMED. THERE WERE NOT ANY ISSUES WITH INSERTION, DEPLOYMENT, OR WITHDRAWAL OF THE DEVICE. SINCE THE PERCLOSE DID NOT WORK MANUAL PRESSURE WAS HELD. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622207 ↗
• MalfunctionJun 15, 2026Difficult to Insert

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE 6 FRENCH ANGIO-SEAL SHEATH AND DILATOR COULD NOT ENTER INTO THE COMMON FEMORAL ARTERY (CFA). A 6 FRENCH SHEATH WAS USED FOR THE INTERVENTION. THE ANATOMY WAS NOT TORTUOUS, LARGER THAN 5MM CFA, AND NO CALCIUM. A PERCLOSE WAS USED AFTER ATTEMPTED USE OF THE ANGIO-SEAL AND NOTHING WORKED. THE PATIENT ENDED UP HAVING A PSEUDOANEURYSM; HOWEVER, THE PATIENT LEFT UNHARMED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WERE NOT ANY DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. THERE WAS A PRE-DEPLOYMENT ANGIOGRAM PERFORMED. THERE WERE NOT ANY ISSUES WITH INSERTION, DEPLOYMENT, OR WITHDRAWAL OF THE DEVICE. SINCE THE PERCLOSE DID NOT WORK MANUAL PRESSURE WAS HELD. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25509162 ↗