CODMAN MICROSENSOR® 626631USRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780514473), received between Feb 17, 2022 and Apr 27, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 12, 2025Open, Classified

   Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

   Z-1036-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2023Pressure Problem; Pressure Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827884 ↗
• InjuryApr 27, 2023Inappropriate Waveform; Inappropriate Waveform

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827880 ↗
• InjuryNov 1, 2022Break; Break

  A FACILITY REPORTED A MICROSENSOR (ID (B)(4) BROKE IN TWO PARTS WHILE REMOVING IT FROM THE PATIENT. THE PROVIDER WAS ABLE TO REMOVE A 3CM PIECE AS WELL AS THE DISTAL PORTION OF THE MICROSENSOR BUT THE SENSOR-TIP ALONG WITH 2 TO 3CM OF SENSOR REMAINED IN THE PATIENT¿S PARENCHYMA.

  Patient problems: Foreign Body In Patient

  MAUDE report 15710909 ↗
• InjuryMay 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A MICROSENSOR ((B)(4)) WAS PLACED ON (B)(6), 2022 AT 10:50 AM AND WAS CONNECTED TO A DIRECT LINK. THE ICP WAS 25 MMHG AFTER IMPLANTATION. NO POST-OP IMAGING WAS OBTAINED. THE DIRECT LINK WAS CONNECTED TO A PHILLIPS MONITOR WHEN THE PATIENT WAS ALREADY IN THE ICU. ON (B)(6) 2022 AT 2300HH THE ICP WAS NOTED TO BE NEGATIVE 4 MMHG TO NEGATIVE 11 MMHG, THEN NEGATIVE 16 MMHG, THEN NEGATIVE 28 MMHG. PER REPORT, THE MONITOR WAS DISCONNECTED AND RECONNECTED. DURING THAT TIME THE PATIENT WAS PLAYING WITH TOYS IN THE HOSPITAL BED, AND DENIED A HEADACHE. WITHIN 45 MINUTES THE ICP WAS 1MMHG THEN 15 MMHG. ON (B)(6), 2022 IN THE MORNING THE PATIENT WAS SLEEPING ON THEIR LEFT SIDE AND THE ICP WAS 25MMHG, THE PATIENT WAS REPOSITIONED AND THE ICP APPROPRIATELY WAS THEN <20 MMHG (NOT A NEGATIVE READING). ON (B)(6) 2022 AT 18:00HH, THE ICP WAS NEGATIVE 2 MMHG. THEN FROM 2100HH UNTIL 0100HH ON (B)(6), 2022, THE ICP WENT TO NEGATIVE 26 MMHG WHILE THE PATIENT WAS ASLEEP WITH HEAD OF BED ELEVATED. ON (B)(6), 2022 AT 0200HH THE ICP WAS 8 MMHG. THE MICROSENSOR WAS REMOVED AND REPLACED ON APRIL 22, 2022. THE ICP WAS 22MMHG WHEN INITIALLY PLACED THEN SETTLED TO A RANGE OF 9-13MM HG. THE PA

  Patient problems: Failure of Implant

  MAUDE report 14340596 ↗
• MalfunctionFeb 17, 2022Low Readings; Low Readings

  A FACILITY REPORTED AN (B)(6) PATIENT COMPLAINED OF HEADACHE RIGHT BEFORE MICROSENSOR WAS PULLED. BASELINE HAS HEADACHES AT HOME, GETTING MONITORED FOR NEW ONSET DOUBLE VISION, PHOTOPHOBIA, NAUSEA WITHOUT VOMITING. PATIENT HAS A HISTORY OF CHIARI MALFORMATION WITH SUBOCCIPITAL DECOMPRESSION, PSEUDOTUMOR CEREBRI AND CYSTOPERIOTEONAL SHUNT. VENTRICULOATRIAL SHUNT WAS PLACED ON (B)(6) 2021 AND CERTAS PLUS SHUNT WAS NOT REVISED IN THE OPERATING ROOM (OR) ON (B)(6) 2022. VALVE SETTING CHANGED TO 8 MORNING OF (B)(6) 2022. ON (B)(6) 2022, MICROSENSOR WAS IMPLANTED AND CONNECTED TO ICP EXPRESS FOR ICP MONITORING, POSITIVE READINGS (17MMHG) WITH APPROPRIATE WAVEFORM. ICP EXPRESS MONITOR WAS DISCONNECTED, AND PATIENT TRANSPORTED TO PEDIATRIC ICU (PICU) AND CONNECTED TO ICP EXPRESS MONITOR IN PICU AFTER CONNECTED, NEGATIVE READINGS SHOWING ON ICP EXPRESS AND PHILIPS BEDSIDE MONITOR WITH FLAT WAVEFORM. 3 DIFFERENT ICP EXPRESS MONITORS AND MULTIPLE TRANSDUCER CABLES WERE CHANGED OUT WITH NO RESOLUTION OF NEGATIVE NUMBER AND FLAT WAVEFORM. PATIENT REMAINED CLINICALLY STABLE, NEUROLOGICAL ASSESSMENT DID NOT MATCH NEGATIVE READINGS/FLAT WAVEFORM, PATIENT¿S HEAD OF BED WAS ELEVATED. ON (B)(6) 2022,

  Patient problems: Headache

  MAUDE report 13552217 ↗