DELTAMAXX DMX180733-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10878528001727), received between Oct 4, 2016 and Sep 21, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 18, 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 21, 2018Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE 7MM X 33CM DELTAMAXX SR PLAT (DMX18073320/C20816) THERMO-MECHANICAL COIL INTRODUCER STARTED TO SHEAR PRIOR TO INSERTION. THE PRODUCT WAS REPLACED TO COMPLETE THE COIL EMBOLIZATION PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND THE EVENT DID NOT RESULT IN A PROCEDURAL DELAY. NO VISIBLE DAMAGE WAS NOTED TO THE PRODUCT PACKAGING, NOR WAS THERE ANY DIFFICULTY EXPERIENCED WHILE REMOVING THE PRODUCT FROM ITS PACKAGING. INVESTIGATION OF THE RETURNED PRODUCT REVEALED THAT THE EMBOLIC COIL WAS KINKED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7897878 ↗
• MalfunctionMay 1, 2018Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PACKAGING ON THE DELTAMAXX SR PLAT 18SYS 7X33 (DMX18073320 / P10921) WAS DEFECTIVE; IT WAS REPORTED THAT THE INNER POUCH HAS AN OPEN SEAL. THE DAMAGE WAS NOTICED AFTER THE PRODUCT WAS RECEIVED AND STORED IN THE LAB ON A CLOSED SHELF. THE DEVICE WAS NOT USED IN PATIENT AS THE STERILITY OF THE DEVICE CANNOT BE GUARANTEED DUE TO THE COMPROMISED SEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7476998 ↗
• MalfunctionOct 4, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A LARGE AVM FISTULA EMBOLIZATION OR AN UNSPECIFIED VESSEL, THE DELTAMAXX COIL (DMX18073320/ P11615) DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH A SAME/LIKE DEVICE. THERE WERE 11 CODMAN COILS DEPLOYED BEFORE THE COIL AND 37 COILS WERE DEPLOYED AFTER THE COIL. ONLY TWO MICROCATHETERS AND 2 CONTROL CABLES WERE USED DURING THE PROCEDURE AND ALL OTHER COILS WERE DEPLOYED NORMALLY. THERE WAS NO RESISTANCE BETWEEN THE COIL AND MICROCATHETER, AND A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE MICROCATHETER DID NOT APPEAR DAMAGED, AND THE COIL WAS REMOVED FROM THE MICROCATHETER, WITHOUT PREMATURE DETACHMENT. THE SAME ENPOWER CABLE AND DETACHMENT CONTROL DEVICE WERE USED TO DETACH SUBSEQUENT COILS. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED. LOW BATTERY LIGHT OR FAULT LIGHT HAD NOT BEE SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED AND THE GREEN SYSTEM READY LIGHT ILLUMINATED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. INFORMATION REGARDIN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5996583 ↗