Flexor G35600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002356009), received between Aug 31, 2016 and Jun 5, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A RADIAL ACCESS CORONARY DIAGNOSTIC PROCEDURE USING A FLEXOR RADIAL ACCESS SET, UPON INSERTION, THE SHEATH FLOWERED BACK AT THE TRANSITION POINT. THE DEVICE WAS REMOVED AND A COMPETITOR'S DEVICE WAS USED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6611609 ↗
• MalfunctionAug 31, 2016Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  DURING AN UNKNOWN PROCEDURE INVOLVING A FLEXOR RADIAL ACCESS SET, IT WAS REPORTED THAT THE VALVE DID NOT WORKED CORRECTLY AND LACK OF BLOOD WAS NOTED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5918198 ↗