Angio-Seal™ Evolution™ (REF C610135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05415067002846), received between Jun 15, 2017 and Oct 22, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT AN ANGIO-SEAL DEVICE WAS IMPLANTED IN HER AND A YEAR LATER AN INFECTION WAS FOUND. THE PATIENT SPENT SEVERAL WEEKS IN THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED ON 10/16/2018: THE PATIENT WAS ADMITTED TO THE ER ON (B)(6) 2017. THE PROCEDURE PERFORMED WAS A PERCUTANEOUS CORONARY INTERVENTION AND TWO STENTS WERE PLACED IN THE PATIENTS' CORONARY ARTERIES. THE INFECTION THEN DEVELOPED AND THE PROBLEMS BEGAN ABOUT THREE MONTHS AFTER THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE ER. THE US OF HER HEART SHOWED A "VEGETATION" AROUND THE AREA WHERE THE STENTS WERE PLACED. ON (B)(6) 2018 THE PATIENT WAS ADMITTED TO THE ER WITH AN INFECTION IN HER CHEST. THE INFECTION WAS IN THE PATIENT'S CHEST AND HAD MIGRATED TO HER SPINE. THE PATIENT STATED THAT THE INFECTION WAS NOT IN HER HEART AND THAT THE INFECTION HAD MIGRATED FROM THE STENTS AROUND HER HEART. THERE WERE NO COMPLICATIONS OR SIGNS OF INFECTION AT THE ACCESS SITE OR WHERE THE ANGIO-SEAL WAS DEPLOYED. THE PATIENT UNDERWENT SURGERY TO HER THORACIC SPINE, HAD CHEST TUBES INSERTED TO DRAIN THE INFECTION IN HER CHEST AND HAD A PICC LINE PLACED FOR LONG TERM IV ANTIBIOTIC THERAPY. AFTER 6 WEEKS, ONCE THE IV

  Patient problems: Unspecified Infection

  MAUDE report 7992004 ↗
• MalfunctionOct 30, 2017Fracture; Fracture

  THE USER FACILITY REPORTED A FRACTURE WITH THE INVOLVED ANGIO-SEAL EVOLUTION. THE FOLLOWING INFORMATION WAS BY THE USER FACILITY; (1) THE SHEATH WAS OPENED AND PLACED ON TABLE, BUT NOT YET INTRODUCED TO PATIENT BEFORE ISSUE NOTED THAT CAUSED THEM TO QUARANTINE. (2) SAW SIGNS OF FRACTURE IN THIS ONE THAT I CAN NOT SEE FROM THE OUTSIDE OF THE QUARANTINED PLASTIC BAG. (3) NO PATIENT WAS INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 6987103 ↗
• MalfunctionOct 25, 2017Fracture; Fracture

  THE USER FACILITY REPORTED THE INVOLVED ANGIO-SEAL EVOLUTION DEVICE WAS IN PIECES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE DOCTOR WENT TO USE AN 8FR EVOLUTION AND IT FELL INTO PIECES IN HIS HANDS; THEY ARE NOT SURE IF IT WAS SOMEHOW CRUSHED IN DISTRIBUTION OR IF IT IS A DEFECT; THERE WAS NO BLOOD LOSS; THE PATIENTS WAS REPORTED TO BE IN GREAT CONDITION AND THE PROCEDURE OUTCOME WAS GREAT; AND ANOTHER 8FR EVOLUTION OFF THE SHELF WAS USED. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 5, 2017. HEMOSTASIS WAS ACHIEVED BY THE SECOND ANGIO-SEAL EVOLUTION DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6976294 ↗
• MalfunctionJun 15, 2017Kinked; Kinked

  THE USER FACILITY REPORTED DIFFICULTY WITH THE INVOLVED ANGIO-SEAL DEVICE. THE USER FACILITY REPORTED: WHEN THEY WENT TO USE THE ANGIO-SEAL DEVICE, THE TIP WAS CRIMPED AT THE END WHERE THE SHEATH IS; IT WAS NOT EASY TO GET THROUGH; AND NO INJURY TO PATIENT. ADDITIONAL INFORMATION ON MAY 23, 2017. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT INCIDENT. THERE WAS NO BLOOD LOSS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6642978 ↗