HydroFrame 18 Advanced 7118-0931Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811425029770), received between Jan 21, 2017 and Jan 21, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2017Difficult to Remove; Stretched; Separation Failure; Difficult to Remove; Stretched; Separation Failure

  IT WAS REPORTED THAT COIL EMBOLIZATION TREATMENT WAS BEING PERFORMED ON A SPLENIC ARTERY ANEURYSM. AFTER THE COIL WAS PLACED IN THE ANEURYSM, IT WOULD NOT DETACH. THE V-GRIP CONTROLLER WAS EXCHANGED, BUT THE COIL STILL WOULD NOT DETACH. AN ATTEMPT WAS MADE TO REMOVE THE ENTIRE COIL; HOWEVER, IT WAS LOCKED IN POSITION IN THE ANEURYSM. THE DELIVERY WIRE WAS TORQUED AT THE PROXIMAL END AND, BELIEVING THE COIL HAD DETACHED, THE DELIVERY WIRE WAS WITHDRAWN; HOWEVER, THE DISTAL PART OF THE DELIVERY WIRE STRETCHED AND THEN BROKE. A FEW CENTIMETERS OF THE HYDROFRAME PLUS A FEW CENTIMETERS OF THE DISTAL DELIVERY WIRE COIL REMAINED IN THE SPLENIC ARTERY. NO ADDITIONAL INTERVENTION WAS PERFORMED AND THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. THE CURRENT PATIENT STATUS IS REPORTED TO BE FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6268846 ↗