Flexor G35598Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002355989), received between Jul 12, 2016 and Mar 10, 2017 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2017Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A CARDIAC CATHETER EXAMINATION, THAT WHEN INSERTING THE FLEXOR RADIAL ACCESS SETS SHEATH, THE TIP OF THE CATHETER WAS NOTED TO BE UNEVEN AND IT WAS NOT POSSIBLE TO INSERT THE INTRODUCERS. IT WAS ALSO NOTED THAT THE TIP OF THE CATHETER STARTED TO DISSOLVE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6395696 ↗
• MalfunctionMar 10, 2017Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A CARDIAC CATHETER EXAMINATION, THAT WHEN INSERTING THE FLEXOR RADIAL ACCESS SETS SHEATH, THE TIP OF THE CATHETER WAS NOTED TO BE UNEVEN AND IT WAS NOT POSSIBLE TO INSERT THE INTRODUCERS. IT WAS ALSO NOTED THAT THE TIP OF THE CATHETER STARTED TO DISSOLVE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6395243 ↗
• InjuryJul 12, 2016Split; Difficult to Advance; Split; Difficult to Advance

  INFORMATION WAS PROVIDED THAT DURING A CARDIAC EXAMINATION/TREATMENT PROCEDURE ON THE FEMALE PATIENT, THE USER EXPERIENCED DIFFICULTY DURING USE OF THE FLEXOR RADIAL ACCESS DEVICE. THE REPORTER STATED THAT IT WASN'T POSSIBLE TO INSERT THE INTRODUCERS AS THEY SPLIT AND POPPED OPEN. IT WAS STATED THAT ALTHOUGH THE DEVICES WERE PROPERLY PREPARED AND USED, PER INSTRUCTION, THE FIRST 2 DEVICES THEY USED DIDN'T WORK; HOWEVER, THE 3RD ONE THEY TRIED WAS FINE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE TIP HURT THE ARTERY OF THE PATIENT FROM THE INSIDE; BUT NO FURTHER DETAILS WERE PROVIDED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REQUESTED BUT AS OF REPORT DATE, NO INFORMATION HAS BEEN GIVEN.

  Patient problems: No Code Available

  MAUDE report 5784825 ↗