Angio-Seal™ STS Plus (REF 610121)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067002877), received between Jul 20, 2017 and Aug 7, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED THAT THE DEVICE DID NOT SEAL INSERTION SITE AS EXPECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THAT ALTHOUGH THEY HEARD THE INSERTION SHEATH AND DEVICE CAP "CLICK" IN PLACE, IT SEPARATED UPON DEPLOYMENT. THE PHYSICIAN HELD MANUAL PRESSURE. THE PATIENT DEVELOPED A HEMATOMA, WHICH REQUIRED DRAINAGE.

  Patient problems: Hematoma

  MAUDE report 6770742 ↗
• MalfunctionJul 20, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL DEVICE FAILED TO CLICK IN PLACE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE DEVICE WAS NOT USED ON THE PATIENT, FOUND PRE-TREATMENT. ANOTHER DEVICE WAS USED TO ACHIEVE HEMOSTASIS.

  Patient problems: No Patient Involvement

  MAUDE report 6728000 ↗