CODMAN MICROSENSOR 82-6638Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20886704042386), received between Jul 25, 2018 and Nov 23, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K914479); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED THAT A MICROSENSOR KIT W/ SKULL BOLT (ID 826638) WAS IMPLANTED ON (B)(6) 2022. AFTER INSTALLING THE SENSOR, THE MONITOR DISPLAYED "-99", MAKING IT IMPOSSIBLE TO MEASURE ACCURATELY. THE MICROSENSOR WAS REMOVED, AND ANOTHER PRODUCT WAS USED AND COMPLETED. IT IS UNKNOWN WHICH MONITOR AND CABLE WERE USED. IT IS UNKNOWN IF THE EVENT LEAD TO AN INCREASE IN SURGERY TIME; HOWEVER, NO PATIENT INJURY OR DEATH OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15858614 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT AFTER DRILLING THE SKULL USING THE DRILL PIT, THE SENSOR WAS PLACED ON (B)(6) 2021. THE PATIENT WAS BEING TRANSPORTED BY EMERGENCY DUE TO A HEAD INJURY. WHEN CONFIRMED BY POSTOPERATIVE CT, THERE WAS SOMETHING THAT SEEMED TO BE BONE DEBRIS IN THE SKULL. THE MICROSENSOR WAS REMOVED ON (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12730414 ↗
• MalfunctionJun 11, 2021Pressure Problem; Pressure Problem

  A FACILITY REPORTED MICROSENSOR SHOWED RANDOM PRESSURE. WHEN THE SENSOR WAS PLACED FOR CALIBRATION, IT SHOWED RANDOM PRESSURES BETWEEN +200 AND -50 MMHG, NOT ALLOWING THE CALIBRATION PROCESS. IT WAS TESTED WITH THREE OTHER MONITORS AND THE FAULT PERSISTED. THE SENSOR WAS REPLACED BY ANOTHER ONE AND IT WORKED CORRECTLY IN THE INITIAL MONITOR. NO PATIENT INJURY REPORTED AND ALMOST 2 HOURS DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11984271 ↗
• MalfunctionSep 17, 2018Defective Device

  DURING ATTEMPTED REMOVAL OF THE ICP CATHETER, A PORTION OF THE CATHETER WAS RETAINED. THE SURGEON ELECTED TO NOT ATTEMPT REMOVAL OF THE REMAINING PIECE. THE RETAINED PIECE HAS WORKED IT'S WAY TO THE SURFACE OF THE PATIENT'S SCALP WHERE RETRIEVAL IS POSSIBLE AND THIS PROCEDURE IS PLANNED. THERE WAS NO KNOWN HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7881187 ↗
• MalfunctionJul 25, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED BY THE OUS AFFILIATE, THAT TWO ICP MICROSENSORS DID NOT WORK, THEY SHOWED -99 DURING THE IMPLANT PROCESS. A NORMAL READING WAS ACHIEVED AFTER A 3RD ICP SENSOR WITH A DIFFERENT BATCH NUMBER WAS USED. THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7718329 ↗
• MalfunctionJul 25, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED BY THE OUS AFFILIATE, THAT TWO ICP MICROSENSORS DID NOT WORK, THEY SHOWED -99 DURING THE IMPLANT PROCESS. A NORMAL READING WAS ACHIEVED AFTER A 3RD ICP SENSOR WITH A DIFFERENT BATCH NUMBER WAS USED. THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7718320 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K914479. One submission often covers many models, so check the product and lot details in each record.

• Z-1614-2023 · Apr 11, 2023 · Open, Classified
  Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Par
• Z-0707-2012 · Oct 25, 2011 · Terminated
  Codman Cranial Access Kit - complete with Xylocaine Product Code: 82-6614 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and th
• Z-0706-2012 · Oct 25, 2011 · Terminated
  Codman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xy