Flexor G07878Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002078789), received between Jan 31, 2017 and Mar 18, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 18, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 09MAR2020. THE HUB SEPARATION OCCURRED DURING REMOVAL OF THE COMPLAINT DEVICE. ACCESS WAS OBTAINED VIA THE RIGHT GROIN AND THE VESSEL WAS CONSIDERED "TIGHTER ACCESS". AN UNKNOWN WIRE GUIDE WAS UTILIZED THROUGH THE COMPLAINT DEVICE, AS WELL AS ANOTHER MANUFACTURER'S BALLOON AND STENT. THE PATIENT'S ANATOMY WAS TORTUOUS AND RESISTANCE WAS ENCOUNTERED. THE SHEATH WAS IN PLACE FOR APPROXIMATELY THIRTY MINUTES. THE DILATOR WAS NOT IN PLACE AT THE TIME OF HUB SEPARATION, NOR WAS ANY OTHER DEVICE. THE ENTIRE SHEATH WAS PULLED FROM THE PATIENT. NO INTERVENTIONS WERE REQUIRED FOR THE SMALL AMOUNT OF BLOOD LOSS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9848248 ↗
• MalfunctionMay 10, 2018Material Frayed; Material Frayed

  IT WAS REPORTED THAT PRIOR TO A STENTGRAFT PLACEMENT, THE DILATOR TIP OF THE FLEXOR INTRODUCER SHEATH WAS FOUND TO BE FRAYED. ANOTHER DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 7502875 ↗
• MalfunctionJan 31, 2017Material Separation; Material Separation

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN EVAR PROCEDURE. THE ATTENDING PHYSICIAN INDICATED BEFORE INSERTING INTO THE PATIENT BODY THE HUB SEPARATED FROM THE SHEATH. THE PHYSICIAN REPLACED FLEXOR INTRODUCER SHEATH AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECTS OR MEDICAL INTERVENTION DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6291721 ↗