DELTAPLUSH DPL100203-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528008057), received between Oct 19, 2016 and Sep 24, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Bent” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2018Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE WITH THE TARGET VESSEL AT THE INTERNAL CAROTID ARTERY (ICA) ON A (B)(6) PATIENT WITH A HISTORY OF HEAD TRAUMA AND WHOSE VESSEL WAS REPORTED TO BE VERY TORTUOUS, THE DELTAPLUSH 10 2MM X 3CM COIL (DPL10020320 / S14053) WAS REPORTED TO HAVE ADVANCING ISSUE. THE COIL COULD NOT ADVANCE THROUGH THE MICROCATHETER (STRYKER, SL-10). THERE WAS NO DAMAGE TO THE COIL OR COIL DETACHMENT SYSTEM PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED INTO THE MICROCATHETER WITH EASE, THAT IT SEEMS STUCK. THE DEVICE WAS PREPPED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU), ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER AT ALL TIMES. THERE WAS NO REPORT OF ANY CLINICAL DELAY TO THE PROCEDURE DUE TO THE REPORTED ISSUE. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR ADVERSE EVENT RELATED TO THE REPORTED ISSUE. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7904207 ↗
• MalfunctionApr 13, 2017Defective Component; Defective Component

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, WHEN THE COIL WAS PULLED OUT OF THE PACKAGE BY THE FELLOW, THE SURGEON THOUGHT THE DELTAPLUSH COIL (DPL10020320/ P11228) WAS LONGER THAN THE SIZE IDENTIFIED ON THE BOX. THE PROCEDURE WAS DELAYED 10 MINUTES DO TO THE EVENT, BUT THERE WERE NO PATIENT ADVERSE EVENTS. THE PROCEDURE WAS COMPLETED WITH A SAME/LIKE PRODUCT. THE DEVICE HAD BEEN STORED ACCORDING TO THE LABELING INSTRUCTIONS. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6490961 ↗
• MalfunctionOct 19, 2016Bent; Deformation Due to Compressive Stress; Bent; Deformation Due to Compressive Stress

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A DELTAPLUSH (DPL10020320/C26897) SHEATH TWISTED DURING ANEURYSM COILING. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE SHEATH DID NOT APPEAR TWISTED; HOWEVER, THE COIL APPEARED COMPRESSED, BUCKLED AND BENT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6039674 ↗