ANGIO-SEALRecalls & reported problems across all models

We found 6 models of ANGIO-SEAL by Terumo Medical Corporation in the FDA's device registry (GUDID). Together they are named in 2,352 adverse event reports in the FDA's MAUDE database, received between Jul 31, 2017 and Sep 29, 2026 — classified as 5 deaths, 1,412 injuries, 935 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (559 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 ANGIO-SEAL problems

ANGIO-SEAL models

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

• ANGIO-SEAL 610130

  Device, hemostasis, vascular
  3 deaths1,651 reports
• ANGIO-SEAL 610131

  Device, hemostasis, vascular
  1 death413 reports
• ANGIO-SEAL C610134

  Device, hemostasis, vascular
  1 death179 reports
• ANGIO-SEAL 610119

  Device, hemostasis, vascular
  53 reports
• ANGIO-SEAL C610135

  Device, hemostasis, vascular
  36 reports
• ANGIO-SEAL 610121

  Device, hemostasis, vascular
  20 reports

Recent ANGIO-SEAL adverse event reports

The 15 most recent reports across all models, 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 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 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 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 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, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50827123 ↗
• 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 ↗

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