iotaSOFT Insertion System IM-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850002960006), received between Aug 30, 2024 and May 1, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Sep 12, 2024Completed

   Incorrect GTIN number.

   Z-0288-2025 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED TO THE COMPANY THAT AFTER A SUCCESSFUL CI ELECTRODE ARRAY PLACEMENT, THE BASE OF THE DRIVE UNIT WAS BEING REMOVED FROM ITS FIXATION (2 SELF-DRILLING SCREWS) ON THE SKULL AND ONE (1) OF THE SCREW HEADS SEPARATED FROM THE SHAFT DURING THE REMOVAL. THE SURGEON WAS ABLE TO REMOVE THE SCREW SHAFT IN ITS ENTIRETY. SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY. THE BROKEN SCREW WAS RETURNED TO THE MANUFACTURER. NO PATIENT HARM REPORTED. FOLLOW-UP STATUS ON PATIENT RECOVERY AND SAFE AND EFFECTIVE USE WITH IMPLANT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944040 ↗
• MalfunctionOct 10, 2024Break; Break

  IT WAS REPORTED TO THE COMPANY THAT AFTER A SUCCESSFUL CI ELECTRODE ARRAY PLACEMENT, THE BASE OF THE DRIVE UNIT WAS BEING REMOVED FROM ITS FIXATION (2 SELF-DRILLING SCREWS) ON THE SKULL AND THE SCREW HEADS SEPARATED FROM THE SHAFT DURING THEIR REMOVAL. THE SURGEON THEN REMOVED THE SCREW SHAFTS BY DRILLING AROUND THEM TO LOOSEN THEM FROM THE SURROUNDING BONE AND WAS ABLE TO REMOVE BOTH SCREW SHAFTS IN THEIR ENTIRETY. SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY. THE COMPANY SCREW PARTS WERE NOT RETURNED TO THE MANUFACTURER. IT WAS REPORTED THAT THE SURGEON DID NOT ELECT TO USE THE SCREWDRIVER THAT ACCOMPANIED THE STERILE, SINGLE USE DRIVE UNIT COMPONENT (RECOMMENDED FOR USE IN THE ACCOMPANYING IFU) BUT RATHER SOURCED THEIR OWN. FOLLOW-UP STATUS ON PATIENT RECOVERY AND SAFE AND EFFECTIVE USE WITH IMPLANT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20422018 ↗
• MalfunctionAug 30, 2024Break; Break

  MANUFACTURER REPRESENTATIVE PRESENT AT SURGERY ADN REPORTED AT CONCLUSION OF USE OF THE MEDICAL DEVICE (FOLLOWING STANDARD PROCEDURES), THE BASE OF THE DRIVE UNIT WAS BEING REMOVED FROM ITS FIXATION (2 SELF-DRILLING SCREWS) ON THE SKULL AND THE SCREW HEAD SEPARATED FROM THE SHAFT ON ONE OF THE TWO SCREWS DURING THEIR REMOVAL. ONE SCREW WAS REMOVED INTACT, THE OTHER SEPARATED (HEAD FROM SHAFT) WITH THE REMOVAL OF THE SCREW HEAD CONSIDERED UNREMARKABLE. THE SURGEON THEN REMOVED THE SCREW SHAFT BY DRILLING AROUND IT TO LOOSEN IT FROM THE SURROUNDING BONE AND WAS ABLE TO REMOVE IT IN ITS ENTIRETY. SURGEON COMPLETED THE PROCEDURE SUCESSFULLY. MANUFACTURER REPRESENTATIVE REQUESTED RETURN OF BOTH PIECES OF SCREW TO COMPANY FOR EVALUATION. IT WAS REPORTED THAT THE SURGEON DID NOT ELECT TO USE THE SCREWDRIVER THAT ACCOMPANIED THE STERILE, SINGLE USE DRIVE UNIT COMPONENT (RECOMMENDED FOR USE IN THE ACCOMPANYING IFU) BUT RATHER SOURCED THEIR OWN. THE COMPONENT (SCREW) IS UNDERGOING INHOUSE AND LABORATORY INSPECTION TO ASCERTAIN CAUSE OF SCREW FAILURE. FOLLOW-UP STATUS ON PATIENT RECOVERY AND SAFE AND EFFECTIVE USE WITH IMPLANT WILL ALSO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20107389 ↗