Codman Microsensor® 826638Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10381780520504), received between Dec 8, 2021 and Mar 30, 2026 — classified as 9 injuries, 2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026No Device Output

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711886 ↗
• InjuryMay 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT THE TIP OF THE MICROSENSOR (ID 826631) WAS TORN OFF WHEN EXPLANTING A WEEK AFTER IMPLANTATION. THE TORN PART REMAINS IN THE PATIENT¿S BODY. CONSIDERING THE ADVANCED AGE OF THE PATIENT (NOT PROVIDED), THERE SEEMS TO BE NO PLAN TO EXPLANT THE REMAINING DEVICE AT THIS POINT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22017752 ↗
• InjuryMar 21, 2025Disconnection; Disconnection

  A PHYSICIAN REPORTED A MICROSENSOR (ID 826638) WAS IMPLANTED ON (B)(6) 2025 AND WAS SECURED USING TAPE. ON (B)(6) 2025, THE SENSOR WAS DISCONNECTED WHILE TRYING TO REPLACE THE TAPE. THEREFORE, THE SENSOR WAS REMOVED ON (B)(6) 2025 AND WAS NOT REPLACED. THE PATIENT IS ON FOLLOW-UP.

  Patient problems: Insufficient Information

  MAUDE report 21664251 ↗
• InjuryFeb 14, 2025Contamination; Contamination

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21384776 ↗
• InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A PHYSICIAN REPORTED A MICROSENSOR (ID 826638) WAS IMPLANTED DUE TO EXTERNAL TRAUMA ON AN UNKNOWN DATE. THE PHYSICIAN DID NOT MAKE ENOUGH INCISION IN DURA MATER AND IMPLANTED THE DEVICE, THEREFORE, THE PATIENT DEVELOPED EPIDURAL HEMATOMA AFTER THE DEVICE WAS IMPLANTED. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE SENSOR FAILED. IT IS ALSO UNKNOWN IF THE SENSOR WAS EXPLANTED DUE TO THIS ISSUE. IT IS UNKNOWN HOW THE EPIDURAL HEMATOMA WAS TREATED. IT IS ALSO UNKNOWN IF THE TRAUMA WAS THE CAUSE OF THE EPIDURAL HEMATOMA. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 19538711 ↗
• InjuryApr 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 19054536 ↗
• InjuryNov 22, 2023No Device Output; No Device Output

  A PHYSICIAN REPORTED THAT AFTER DOING STEP BY STEP THE CALIBRATION OF THE MICROSENSOR WITH THE DIRECTLINK, IT WAS NOT POSSIBLE TO ACHIEVE A CURVE AND NUMBER IN THE BEDSIDE MONITOR, ONLY A QUESTION MARK APPEARS. THEY RECALIBRATE THE MICROSENSOR FOLLOWING THE INSTRUCTIONS WITHOUT OBTAINING RESULTS, THEREFORE, THE SENSOR WAS EXPLANTED. THE EVENT LED TO 4 HOURS DELAY IN THE PROCEDURE, HOWEVER, NO ANESTHESIA WAS INVOLVED AS THE PATIENT WAS ALREADY SEDATED AND INTUBATED IN THE ICU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192903 ↗
• InjuryAug 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A NURSE REPORTED A MICROSENSOR (ID: (B)(4) TIP WAS UNABLE TO PROVIDE ACCURATE INTRACRANIAL PRESSURE (ICP) READING. THE MONITOR USED WAS ICP EXPRESS (UNKNOWN ID) AND CABLE USED WAS ICP CABLE (UNKNOWN ID). THE EVENT HAPPENED DURING THE PROCEDURE AFTER IMPLANTATION SITE CLOSURE. THE REPORTED MICROSENSOR WAS CHANGED TO A NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 17586007 ↗
• InjuryNov 28, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A MICROSENSOR (ID 826638) WAS IMPLANTED WITH SETTING 2 ON (B)(6) 2022 HOWEVER, ON (B)(6) 2022 THE PRESSURE WAS SWITCHED TO PRESSURE SETTING 6 ON ITS OWN. NO PATIENT SIGNS AND SYMPTOMS. THEREFORE, THE MICROSENSOR WAS REMOVED AND REPLACED ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15873898 ↗
• MalfunctionJan 26, 2022High Readings; High Readings

  A FACILITY REPORTED A MICROSENSOR SHOWED ABNORMAL HIGH READING AFTER ZEROING. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT CONTACT/INJURY AND THE EVENT LED TO AROUND HALF AN HOUR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13357793 ↗
• MalfunctionDec 8, 2021Output Problem; Output Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12964946 ↗

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