DELTAPLUSH DPL100152-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528008019), received between Aug 24, 2016 and Jul 14, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 14, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THE DETACH TIP SIDE OF THE DELTAPLUSH COIL ((B)(4)) IS LONGER THAN OTHER COILS AND WILL PUSH OUT OF THE MICROCATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6714981 ↗
• MalfunctionAug 24, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING LEFT ANTERIOR COMMUNICATING ARTERY COIL EMBOLIZATION, UPON ATTEMPTING TO DEPLOY A DELTAPLUSH COIL ((B)(4)), THE PHYSICIAN WAS UNABLE TO DETACH THE COIL. THE PHYSICIAN HAD ALREADY SUCCESSFULLY IMPLANTED AND DETACHED SEVERAL COILS USING THE SAME ENPOWER CABLE AND DCB. SEVERAL ATTEMPTS WERE MADE TO DETACH THE DELTAPLUSH WITH NO SUCCESS. THE PHYSICIAN THEN REMOVED THE COIL IN QUESTION WITHOUT DIFFICULTY, AND THERE WAS NO DAMAGE NOTED TO THE COIL (I.E. KINKED, STRETCHED, SEPARATED, DETACHED). A DIFFERENT DELTAPLUSH OF THE SAME SIZE WAS IMPLANTED AND SUCCESSFULLY DETACHED USING A REPLACEMENT CABLE AND THE SAME DCB WITH NO ISSUE. IT WAS CONFIRMED THAT HERE WAS NO ISSUE WITH THE INITIAL CABLE AND DCB. WHEN ATTEMPTING TO DETACH THE COIL, THE LIGHTS DID NOT ILLUMINATE AS EXPECTED. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD NOT BEEN PERFORMED. ALL CONNECTIONS FIT PROPERLY WITHOUT NEED FOR EXCESSIVE FORCE. THERE WAS NO RESISTANCE BETWEEN THE COIL AND MICROCATHETER, AND A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. NO FURTHER DETAILS WERE PROVIDED REGARDING THE COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5901050 ↗