DELTAPLUSH DPL100202-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528008040), received between Feb 6, 2018 and Jun 5, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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.

• MalfunctionJun 5, 2019Entrapment of Device; Stretched; Material Deformation; Entrapment of Device; Stretched; Material Deformation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING THE ANEURYSM ON THE TERMINAL INTERNAL CAROTID ARTERY (ICA), THE 2MM X 2CM DELTAPLUSH 10 COIL (DPL10020220 / S10016) DELIVERED THROUGH THE SL-10® MICROCATHETER (STRYKER) WAS REPORTED TO BE STIFF; THE STIFFNESS CAUSED THE COIL TO PUSH A LOOP OF A PREVIOUSLY PLACED 3MM X 5.4CM MICRUSFRAME 10 COIL (MFR100305 / UNK LOT) INTO THE PARENT VESSEL. AS A RESULT, A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS SUBSEQUENTLY PLACED TO SECURE THE COIL TO THE PARENT VESSEL WALL. A 2 MM X 2 CM BARRICADE¿ HELICAL COIL (BLOCKADE MEDICAL) WAS USED TO REPLACE THE DELTAPLUSH COIL AFTER THE STENT PLACEMENT WITHOUT INCIDENT. IT WAS REPORTED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER; THE DELTAPLUSH COIL HAD BEEN REPOSITIONED ONCE. THE DELTAPLUSH COIL WAS REMOVED THROUGH THE MICROCATHETER UNDETACHED AND WITHOUT ANY OBSERVABLE DAMAGE. THERE WAS NO PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED EVENT. THE PRODUCT WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670593 ↗
• MalfunctionFeb 6, 2018Positioning Failure; Positioning Failure

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF AN UNKNOWN SITE, THE DELTAPLUSH COIL (DPL10020220, UNKNOWN LOT NUMBER), WAS IN THE MICROCATHETER (MC) AND POSITIONED IN THE PATIENT, HOWEVER, IT WAS NOT POSSIBLE FOR THE DOCTOR TO DETACH THE COIL. THERE WAS NO PATIENT INJURY REPORTED. IT¿S UNKNOWN OF THE DEVICE IS AVAILABLE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7244909 ↗