DELTAPLUSH DPL100206-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528008071), received between Dec 20, 2016 and Jan 17, 2018 — classified as 3 malfunctions.

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

• MalfunctionJan 17, 2018Kinked; Stretched; Kinked; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAPLUSH COIL (DPL10020620/P10799) EXPERIENCED RESISTANCE IN THE MICROCATHETER AND COULD NOT BE USED DURING A RE-TREATMENT OF A BASILAR APEX ANEURYSM PROCEDURE, PREVIOUSLY STENTED/COILED (ONLY 1 COIL USED ON FIRST TREATMENT AXIUM 4 MM COIL). REPORTEDLY, ONE COIL WAS IN AND THE SECOND COIL CAME OUT OF THE STENT STRUT. THE COIL WAS REMOVED AND THE PHYSICIAN DECIDED TO LET STENT HEAL FOR FEW MONTHS THEN BRING THE PATIENT BACK AND TREAT. THE PATIENT¿S VESSEL WAS MODERATELY TORTUOUS. A 6FR. SHEATH RT. WAS ADVANCED THROUGH THE FEMORAL ARTERY, A 6FR ENVOY GUIDE TO LT. VERTEBRAL ARTERY, AND AN ECHELON 10 MICROCATHETER AND XPEDION 014¿ GUIDEWIRE WERE ADVANCED TO THE ANEURYSM THROUGH THE STENT STRUT. TWO MICRUSPHERE 10 3.5 MM X 6.6 CM COILS WERE DELIVERED AND DETACHED, FOLLOWED BY TWO MICRUSPHERE 2 MM X 2.5 CM COILS THAT WAS DELIVERED AND DETACHED. A DELTAPLUSH 2X6 COIL (COMPLAINT PRODUCT) WAS THE NEXT COIL OPENED. AN ATTEMPT WAS MADE TO LOAD THE DELTAPLUSH INTO THE MICROCATHETER, HOWEVER, THE SCRUB TECH STATED THAT THE COIL WAS NOT ADVANCING EASILY AND THE PHYSICIAN REMOVED THE COIL FROM THE MICROCATHETER. THE PHYSICIAN SAID THE COIL IS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7201805 ↗
• MalfunctionDec 7, 2017Kinked; Stretched; Kinked; Stretched

  AT A HEALTHCARE FACILITY, A USED DELTAPLUSH COIL (DPL10020620/ S10357) WAS FOUND ON THE SHELF AND HAD BEEN SITTING THERE FOR UP TO A YEAR; HOWEVER, THE FACILITY DID NOT KNOW WHAT THE ACTUAL COMPLAINT HAD BEEN. DURING PRODUCT ANALYSIS, IT WAS FOUND THAT THE COIL WAS STRETCHED, DETACHED AND KINKED. THE SALES REPRESENTATIVE INFORMED THE CUSTOMER ABOUT THE IMPORTANCE OF REPORTING ANY COMPLAINTS AS SOON AS POSSIBLE TO JOHNSON AND JOHNSON. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7094997 ↗
• MalfunctionDec 20, 2016Positioning Failure; Stretched; Positioning Failure; Stretched

  THE CONTACT FROM THE FACILITY REPORTED THAT DURING COILING OF ANEURYSM, THE DELTAPLUSH COIL (DPL10020620/C30217) COULD NOT BE DETACHED EVEN AFTER CHANGING THE CONTROL CABLE AND DETACHMENT CONTROL BOX (BOTH DETAILS UNKNOWN.) THE PROCEDURE WAS COMPLETED WITH A SAME/LIKE DEVICE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. AT THE TIME OF INITIAL CONTACT THE DEVICE WAS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6190294 ↗