CODMAN MICROSENSOR 82-6631Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20886704042317), received between Jul 23, 2018 and Nov 28, 2022 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2022No Device Output; No Device Output

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870519 ↗
• InjuryJul 13, 2022Failure to Read Input Signal; Failure to Read Input Signal

  A FACILITY REPORTED A NEUROMONITOR BASIC KIT (ID 826631) WAS PLACED ON (B)(6) 2022. AFTER THE PATIENT WAS SENT BACK TO WARD THE MICROSENSOR COULD NOT SHOW A NORMAL READINGS. THEY CHANGED WITH A NEW ICP MONITOR (ID 826635) AND NEW CABLE HOWEVER, THE MICROSENSOR STILL COULD NOT SHOW NORMAL READING WITH P-0 ON THE MONITOR AND COULD NOT ENTER INTO THE NEXT STEP. THEREFORE, THE MICROSENSOR WAS REMOVED ON (B)(6) 2022 AND MONITORING WAS STOPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15001104 ↗
• MalfunctionJun 21, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  A FACILITY REPORTED A BOX OF A NEUROMONITOR BASIC KIT (ID 826631) WAS CRUSHED BEFORE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO SURGICAL DELAY AND ADVERSE CONSEQUENCES TO THE PATIENT WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14755503 ↗
• InjuryJun 21, 2022Break; Break

  A PHYSICIAN REPORTED THE TIP OF A MICROSENSOR (ID 826631) WAS CAUGHT BETWEEN THE SPACE OF THE AUTOLOGOUS BONE AND THE FLAP SEEMED TO BE NARROW, LEAVING ONLY THE TIP TRANSECTED INSIDE THE BODY. SENSOR WAS REMOVED AND THE TIP WAS STILL INSIDE THE BODY. IT IS UNKNOWN IF AN X-RAY WAS TAKEN OR WHAT ACTION WAS IMPLEMENTED. PATIENT CONDITION IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 14755007 ↗
• MalfunctionFeb 16, 2022Connection Problem; Connection Problem

  A PHYSICIAN REPORTED THAT WHEN THE OPERATOR OPENED THE MICROSENSOR ((B)(4)) AND CONNECTED IT TO THE MAIN UNIT DURING THE SURGERY, IT WAS NOT RECOGNIZED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. THE ISSUE WAS DETECTED BEFORE THE IMPLANTATION SITE CLOSURE. NO SURGICAL DELAY OR ADVERSE CONSEQUENCES TO THE PATIENT WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542728 ↗
• MalfunctionFeb 10, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  A FACILITY REPORTED A MICROSENSOR ((B)(4)) WITH ASEPTIC PACKING DAMAGED. THE EVENT OCCURRED DURING THE PROCEDURE WHILE THE PHYSICIAN WAS UNPACKING THE OUTER PACKAGE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. THERE WAS NO DELAY AND NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13508244 ↗
• MalfunctionFeb 8, 2022Connection Problem; Connection Problem

  A FACILITY REPORTED THE ICP MONITOR COULD NOT DETECT THE MICROSENSOR AFTER BEING IMPLANTED; BEFORE IMPLANTATION SITE CLOSURE. THE SURGEON CHANGED WITH A NEW MICROSENSOR. THE EVENT LED TO 10 MINUTES SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13485362 ↗
• InjuryJan 11, 2022No Device Output; No Device Output

  A FACILITY REPORTED A MICROSENSOR WAS IMPLANTED ON (B)(6) 2021, THREE DAYS LATER IT COULD NOT BE DETECTED AND WAS EXPLANTED ON (B)(6) 2021. PATIENT IS IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 13228993 ↗
• MalfunctionDec 16, 2021Connection Problem; Connection Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022127 ↗
• MalfunctionNov 17, 2021Output Problem; Output Problem

  A FACILITY REPORTED THAT AFTER THE NEUROMONITOR BASIC KIT (ID 826631) WAS IMPLANTED, THE ICP DID NOT SHOW THE ICP READINGS. THE ICP MONITOR USED WAS ICP EXPRESS, 220 VOLT (ID 826635). THE ISSUE WAS DETECTED BEFORE THE SITE CLOSURE AND THE EVENT LED TO 10 MINUTES SURGICAL DELAY. THE REPORTED MICROSENSOR WAS CHANGED TO A NEW ONE. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12830470 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED A PATIENT WAS SENT TO THE HOSPITAL DUE TO AN ANEURYSM RUPTURE AND SUBARACHNOID HEMORRHAGE. THEN THE PHYSICIAN CONDUCTED THE PARAVENTRICULOSTOMY WITH MEDTRONIC EXTERNAL VENTRICULAR DRAINAGE SYSTEM AND ICP MICROSENSOR IMPLANTATION WITH THE CODMAN MICROSENSOR ON (B)(6) 2020. AFTER THE PROCEDURE, THE PATIENT GOT INFECTION TREATED WITH ANTIBIOTICS AND SECONDARY HYDROCEPHALUS. THE CAUSE OF THE INFECTION WAS NOT CONFIRMED AND THE TYPE OF ORGANISM IS UNKNOWN.

  Patient problems: Hydrocephalus; Unspecified Infection

  MAUDE report 12708326 ↗
• MalfunctionJul 1, 2021Peeled/Delaminated; Peeled/Delaminated

  A PHYSICIAN REPORTED THAT AFTER UNPACKING THE MICROSENSOR, IT WAS FOUND THAT SHELL WAS PEELED OFF BUT IT COULD BE ZEROED NORMALLY AND COULD SHOW NORMAL READING. THE MICROSENSOR WAS IMPLANTED TO THE PATIENT AND WAS MONITORED DURING THE PROCEDURE. HOWEVER, AFTER THE MONITORING THE MICROSENSOR WAS DISCARDED. THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104951 ↗
• MalfunctionJul 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  N/A.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10221156 ↗
• MalfunctionJul 23, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED BY THE AFFILIATE, A MICROSENSOR WAS GIVING NEGATIVE READINGS DURING IMPLANTATION, A NEW MICROSENSOR WAS SUCCESSFULLY USED TO GET ICP READINGS. THE NEGATIVE READINGS WERE NOTED, THE DIRECT LINK CABLE WAS CHANGED; HOWEVER, THAT DID NOT FIX THE ISSUE, THEN THE MICROSENSOR WAS REPLACED. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7710157 ↗

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-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
• 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