Angio-Seal™ STS Plus (REF 610119)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067002860), received between Aug 22, 2017 and Aug 24, 2017 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THERE WAS AN ISSUE POST PROCEDURE BY A WEEK OR MORE WHERE THE PATIENT HAD BEEN RE-ADMITTED TO FACILITY WITH AN INFECTION IN THE RIGHT GROIN WHERE THE ANGIOSEAL DEVICE WAS DEPLOYED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THERE WERE NO KNOWN BLEEDING COMPLICATIONS. BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT CONDITION AND PROCEDURE OUTCOME IS UNKNOWN AT THE TIME. IT WAS REPORTED THAT THEY DID NOT THINK IT WAS AN ANGIOSEAL DEVICE FAILURE AND WOULD EXPLAIN WHAT HE FELT HAPPENED AND WHY THEY HAVE SUBMITTED TO THE FDA WITH A RESPONSE THERE LOOKS TO BE NO LINK A DEVICE FAILURE.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 6817633 ↗
• MalfunctionAug 23, 2017Kinked; Kinked

  THE USER FACILITY REPORTED THAT DOCTOR HAD FOUR ANGIO-SEAL STS DEVICES WHERE THE DEVICE WAS KINKING WHEN ATTEMPTING TO DEPLOY. EACH TIME THEY HAD TO CUT THE DEVICE TO DEPLOY THE ANGIO-SEAL. THE PATIENT CONDITION WAS REPORTED TO BE FINE. ADDITIONAL INFORMATION WAS RECEIVED ON 7/28/2017: THE DOCTOR HAD ISSUE WITH DEPLOYING 6FR STS ANGIOSEAL, FOUR CONSECUTIVE DEVICES FAILED. IT WAS REPORTED THAT THE SHEATH GETS STUCK INSIDE THE PATIENT ONCE THE DILATOR AND WIRE ARE TAKEN OUT AND BOTH DEVICES ARE CLICKED TOGETHER WHEN SHE PULLS BACK THE SHEATH IS STUCK IN THE PATIENT AND SHE HAS TO CUT THE SUTURE TO PULL THE SHEATH OUT. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE WITH NO ISSUES. IT WAS REPORTED THAT THERE WERE NO ISSUES WITH THE PROCEDURE OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED ON 8/2/17: HEMOSTASIS WAS ABLE TO BE ACHIEVED WITH THE DEVICE ONCE THE SUTURE WAS CUT. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250 CC. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6812969 ↗
• MalfunctionAug 23, 2017Kinked; Activation, Positioning or Separation Problem; Kinked; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT DOCTOR HAD FOUR ANGIO-SEAL STS DEVICES WHERE THE DEVICE WAS KINKING WHEN ATTEMPTING TO DEPLOY. EACH TIME THEY HAD TO CUT THE DEVICE TO DEPLOY THE ANGIO-SEAL. THE PATIENT CONDITION WAS REPORTED TO BE FINE. ADDITIONAL INFORMATION WAS RECEIVED ON 7/28/2017: THE DOCTOR HAD ISSUE WITH DEPLOYING 6FR STS ANGIOSEAL, FOUR CONSECUTIVE DEVICES FAILED. IT WAS REPORTED THAT THE SHEATH GETS STUCK INSIDE THE PATIENT ONCE THE DILATOR AND WIRE ARE TAKEN OUT AND BOTH DEVICES ARE CLICKED TOGETHER WHEN SHE PULLS BACK THE SHEATH IS STUCK IN THE PATIENT AND SHE HAS TO CUT THE SUTURE TO PULL THE SHEATH OUT. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE WITH NO ISSUES. IT WAS REPORTED THAT THERE WERE NO ISSUES WITH THE PROCEDURE OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED ON 8/2/17: HEMOSTASIS WAS ABLE TO BE ACHIEVED WITH THE DEVICE ONCE THE SUTURE WAS CUT. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250CC. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 6812752 ↗
• MalfunctionAug 23, 2017Kinked; Activation, Positioning or Separation Problem; Kinked; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT DOCTOR HAD FOUR ANGIO-SEAL STS DEVICES WHERE THE DEVICE WAS KINKING WHEN ATTEMPTING TO DEPLOY. EACH TIME THEY HAD TO CUT THE DEVICE TO DEPLOY THE ANGIO-SEAL. THE PATIENT CONDITION WAS REPORTED TO BE FINE. ADDITIONAL INFORMATION WAS RECEIVED ON 7/28/2017: THE DOCTOR HAD ISSUE WITH DEPLOYING 6FR STS ANGIOSEAL, FOUR CONSECUTIVE DEVICES FAILED. IT WAS REPORTED THAT THE SHEATH GETS STUCK INSIDE THE PATIENT ONCE THE DILATOR AND WIRE ARE TAKEN OUT AND BOTH DEVICES ARE CLICKED TOGETHER WHEN SHE PULLS BACK THE SHEATH IS STUCK IN THE PATIENT AND SHE HAS TO CUT THE SUTURE TO PULL THE SHEATH OUT. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE WITH NO ISSUES. IT WAS REPORTED THAT THERE WERE NO ISSUES WITH THE PROCEDURE OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED ON 8/2/2017: HEMOSTASIS WAS ABLE TO BE ACHIEVED WITH THE DEVICE ONCE THE SUTURE WAS CUT. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250 CC. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 6812747 ↗
• MalfunctionAug 22, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT DOCTOR HAD FOUR ANGIO-SEAL STS DEVICES WHERE THE DEVICE WAS KINKING WHEN ATTEMPTING TO DEPLOY. EACH TIME THEY HAD TO CUT THE DEVICE TO DEPLOY THE ANGIO-SEAL. THE PATIENT CONDITION WAS REPORTED TO BE FINE. ADDITIONAL INFORMATION WAS RECEIVED ON 7/28/2017: THE DOCTOR HAD ISSUE WITH DEPLOYING 6FR STS ANGIOSEAL, FOUR CONSECUTIVE DEVICES FAILED. IT WAS REPORTED THAT THE SHEATH GETS STUCK INSIDE THE PATIENT ONCE THE DILATOR AND WIRE ARE TAKEN OUT AND BOTH DEVICES ARE CLICKED TOGETHER WHEN SHE PULLS BACK THE SHEATH IS STUCK IN THE PATIENT AND SHE HAS TO CUT THE SUTURE TO PULL THE SHEATH OUT. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE WITH NO ISSUES. IT WAS REPORTED THAT THERE WERE NO ISSUES WITH THE PROCEDURE OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED ON 8/2/2017: HEMOSTASIS WAS ABLE TO BE ACHIEVED WITH THE DEVICE ONCE THE SUTURE WAS CUT. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250 CC. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6811555 ↗