HyperSoft 3D Advanced 8410-0408Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811425028094), received between Jan 13, 2017 and Mar 7, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2017Detachment Of Device Component; Stretched; Separation Failure; Detachment Of Device Component; Stretched; Separation Failure

  IT WAS REPORTED THAT AFTER POSITIONING AN EMBOLIZATION COIL IN AN ANEURYSM, THE COIL WOULD NOT DETACH. MULTIPLE ATTEMPTS WERE MADE TO DETACH THE COIL, WITHOUT SUCCESS. DURING REMOVAL, THE COIL STRETCHED AND DETACHED. THE COIL WAS PUSHED BACK INTO THE ANEURYSM WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY. THE CURRENT PATIENT'S STATUS IS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6386343 ↗
• MalfunctionJan 13, 2017Detachment Of Device Component; Difficult To Position; Stretched; Detachment Of Device Component; Difficult To Position; Stretched

  IT WAS REPORTED THAT WHILE TREATING A 4MM ICA TERMINUS ANEURYSM, AN LVIS JR WAS DEPLOYED FROM MCA TO ICA. A HYPERSOFT 3D 3.5X8 WAS DEPLOYED AND DETACHED, THEN ANOTHER HYPERSOFT 3D 2.5X6 WAS DEPLOYED AND DETACHED. THE THIRD HYPERSOFT 3D COIL OVERSHOT THE LANDING ZONE BY 1CM. SUGGESTION WAS MADE TO PULL THE COIL BACK AND IF RESISTANCE WAS ENCOUNTERED IT WAS SUGGESTED TO STOP. RESISTANCE WAS ENCOUNTERED AND HE STOPPED. IT WAS THEN SUGGESTED TO DETACH THE COIL AND HE DID. WHEN HE REMOVED THE COIL, WE NOTICED THE DISTAL COIL OF THE PUSHER HAD STRETCHED BUT THE COIL WAS DEPLOYED SAFELY. WE THEN SWITCHED TO AN SL10 BECAUSE IT IS SOFTER. A 2X3 HYPERSOFT 3D WAS THEN USED, THE COIL WAS NOT SITTING IN THE ANEURYSM, IT KEPT POPPING OUT INTO A1. THE COIL WAS PULLED BACK GENTLY TO BE REPOSITIONED AND WHEN WE WENT TO PUSH THE COIL WE REALIZED IT HAD SPONTANEOUSLY DETACHED. THE COIL WAS STILL IN THE ANEURYSM AND CATHETER TIP WAS OUT OF THE ANEURYSM. THE PHYSICIAN PUSHED A 2X4 STRYKER 360 STANDARD AND WHEN HE FELT RESISTANCE IN THE CATHETER HE STOPPED AND PULLED THE CATHETER OUT EFFECTIVELY DRAGGING OUT THE DETACHED HYPERSOFT 3D WHICH WAS HALF IN THE ANEURYSM AND HALF IN THE MICROCATHETER. NO REPOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6248511 ↗