DELTAPLUSH DPL100204-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528008064), received between Mar 6, 2017 and Sep 22, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• MalfunctionSep 22, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAPLUSH COIL, 10 SYS 2X4 COIL (DPL10020420, L11248) BECAME STRETCHED WHILE IN USE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10567162 ↗
• MalfunctionMar 6, 2017Material Separation; Material Separation

  THE CONTACT FROM THE FACILITY REPORTED THAT DELTAPLUSH COIL (DPL10020420/P11075) STRETCHED AND WAS SEPARATED IN THE MICROCATHETER WHEN IT WAS WITHDRAWN. THE ANEURYSM WAS SACCULAR AND THE SIZE OF THE ANEURYSM IS UNKNOWN. THE PHYSICIAN PLACED THE FIRST COIL (CASHMERE, DETAILS UNKNOWN) WITHOUT ANY PROBLEMS. THEN HE WANTED TO PLACE THE DELTAPLUSH COIL. THE COIL REACHED THE ANEURYSM BUT THE PHYSICIAN WANTED TO CHANGE ITS POSITION, SO HE REMOVED IT FROM THE ANEURYSM INTO THE MICROCATHETER (EXCELSIOR SL10, DETAILS UNKNOWN.) WHEN HE PULLED IT BACK INTO THE MICROCATHETER THE DELTAPLUSH COIL WAS STRETCHED AND THEN SNAP OFF IN THE MICROCATHETER. THE PHYSICIAN HAD TO REMOVE THE ENTIRE MICROCATHETER WITH THE SNAPPED COIL. AFTER THAT EVENT HE PLACED A NEW MICROCATHETER IN THE ANEURYSM AND CONTINUED THE PROCEDURE. NO SIGNIFICANT DELAY GREATER 30 MINUTES REPORTED NOR CONSEQUENCES FOR THE PATIENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED AT ALL TIMES. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND MICROCATHETER WHEN ACCESSING THE TARGET SITE. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. ONE OTHER COIL (DETAILS UNKNOWN) WENT THROUGH THE SAME MIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382981 ↗