INVOSRecalls & reported problems across all models

We found 35 models of INVOS by Covidien LP in the FDA's device registry (GUDID). Together they are named in 323 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2017 and Aug 21, 2025 — classified as 4 deaths, 18 injuries, 301 malfunctions.

The most frequently reported specific device problem is “Low Readings” (128 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

INVOS recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 9, 2024Open, Classified

   manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel

   Z-1732-2024 · Root cause: Process design · Recall details · FDA record ↗

2. Jan 9, 2024Open, Classified

   manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel

   Z-1731-2024 · Root cause: Process design · Recall details · FDA record ↗

Most reported INVOS problems

INVOS models

35 models, most reported first. Each model has its own page with its reports, recalls and device details.

• INVOS PMAC71RSC

  Oximeter, tissue saturation
  1 recall67 reports
• INVOS PMAC71RIC

  Oximeter, tissue saturation
  1 recall4 reports
• Invos 5100C-EU

  Oximeter, tissue saturation
  22 reports
• INVOS PM7100

  Oximeter, tissue saturation
  21 reports
• INVOS PM7100

  Oximeter, tissue saturation
  18 reports
• INVOS 5100C-PA

  Oximeter, tissue saturation
  15 reports
• INVOS 5100C-US

  Oximeter, tissue saturation
  1 death14 reports
• INVOS DS5100C-PA

  Oximeter, tissue saturation
  11 reports
• INVOS DS5100C-US

  Oximeter, tissue saturation
  11 reports
• INVOS PMSENS71-A

  Oximeter, tissue saturation
  11 reports
• INVOS PMPAMP71

  Oximeter, tissue saturation
  11 reports
• INVOS CNN/SNN

  Oximeter, tissue saturation
  11 reports
• INVOS DS5100C-PB

  Oximeter, tissue saturation
  10 reports
• INVOS PM7100

  Oximeter, tissue saturation
  9 reports
• INVOS SAFB-SM/INTL

  Oximeter, tissue saturation
  9 reports
• INVOS 5100C-PB

  Oximeter, tissue saturation
  8 reports
• INVOS PMSENS71-A

  Oximeter, tissue saturation
  8 reports
• INVOS CNN/SNN

  Oximeter, tissue saturation
  1 death8 reports
• INVOS PMPAMP71

  Oximeter, tissue saturation
  7 reports
• INVOS SAFB-SM/INTL20

  Oximeter, tissue saturation
  1 death7 reports
• INVOS DL5100C-US

  Oximeter, tissue saturation
  5 reports
• INVOS IS

  Oximeter, tissue saturation
  1 death5 reports
• INVOS PMPAMP71

  Oximeter, tissue saturation
  5 reports
• INVOS PMAC71DOC

  Oximeter, tissue saturation
  5 reports
• INVOS SPFB/INTL

  Oximeter, tissue saturation
  4 reports
• INVOS IS

  Oximeter, tissue saturation
  3 reports
• INVOS IS-C

  Oximeter, tissue saturation
  3 reports
• INVOS RSC-1

  Oximeter, Tissue Saturation
  2 reports
• INVOS 5100C-JP

  Oximeter, tissue saturation
  2 reports
• INVOS SNN

  Oximeter, tissue saturation
  2 reports
• INVOS RSC-2

  Oximeter, Tissue Saturation
  1 report
• INVOS RSC-4

  Oximeter, Tissue Saturation
  1 report
• INVOS SPFB/USA

  Oximeter, tissue saturation
  1 report
• INVOS PMC71V-GE

  Oximeter, Tissue Saturation
  1 report
• INVOS PMSENS71-P

  Oximeter, tissue saturation
  1 report

Recent INVOS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Incorrect Measurement; Material Split, Cut or Torn; Incorrect Measurement; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE MONITOR CABLE WAS DAMAGED AND DID NOT READ CORRECTLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22860037 ↗
• MalfunctionAug 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN INTENSIVE CARE UNIT (ICU) AND PART OF A RESEARCH STUDY, THERE WAS A SKIN INTEGRITY ON THE FOREHEAD AND THE SENSORS WERE PERMANENTLY REMOVED. PATIENT EXPERIENCED DEEP TISSUE INJURY ON THE LEFT FOREHEAD AND STAGE TWO ULCERS ON THE RIGHT FOREHEAD. THE STUDY PROBES WAS APPLIED, PATIENT CRITICALLY ILL ON MULTIPLE VASOPRESSORS THROUGHOUT HIS ADMISSION. STUDY PROBES REMOVED ONCE ULCERS NOTED. THE PATIENT WAS PRESENT ALIVE AND ON LIFE SUPPORT DUE TO THEIR PREEXISTING CONDITION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 22785139 ↗
• MalfunctionJul 30, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT PRIOR SURGERY, THE PREAMPLIFIER WAS NOT CAPTURING THE DATA CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668841 ↗
• MalfunctionJul 8, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE UNIT DID NOT READ CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438225 ↗
• MalfunctionJun 27, 2025Communication or Transmission Problem; Manufacturing, Packaging or Shipping Problem; Communication or Transmission Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING USE, THE MONITOR WAS NOT DETECTING THE SENSOR CONNECTED ON A PATIENT, OR WAS ONLY DETECTING ONE SIDE. THE ISSUE WAS OBSERVED WITH A BRAND NEW MONITOR. A NEW MONITOR WAS USED, AND THERE WAS NO ISSUE WITH THE REPLACEMENT. THERE WAS UNSPECIFIED PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22347350 ↗
• MalfunctionJun 27, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE UNIT HAD INCORRECT READING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345343 ↗
• MalfunctionJun 17, 2025Device Alarm System; Incorrect Measurement; Communication or Transmission Problem; Device Alarm System; Incorrect Measurement; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING USE, AFTER CONNECTING THE MONITORING PROBE, IT WAS FOUND THAT THE DATA COULD NOT BE READ NORMALLY. IT WAS IMMEDIATELY REPLACED TO CONTINUE MONITORING THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22237847 ↗
• MalfunctionJun 2, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT THE UNIT EXHIBITED LOW RSO2 READINGS, WITH A BASELINE OF 58 OR A 20% DECREASE FROM THE EXPECTED BASELINE. TWO SIMILAR INCIDENTS HAD PREVIOUSLY OCCURRED IN THE SAME BLOCK. DURING CEREBRAL PERFUSION MONITORING UNDER ALR AND SEDATION, APPROXIMATELY 30 MINUTES AFTER CLAMPING THE CAROTID ARTERY, THE SENSOR ON THE RIGHT SIDE DISPLAYED AN UNEXPLAINED DROP IN VALUES, SUGGESTING CEREBRAL HYPOPERFUSION. HOWEVER, NO CLINICAL CHANGES WAS OBSERVED. THE ISSUE WAS RESOLVED BY REPLACING THE SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127500 ↗
• MalfunctionMay 22, 2025Failure to Analyze Signal; Communication or Transmission Problem; Material Split, Cut or Torn; Failure to Analyze Signal; Communication or Transmission Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD NO RSO2 READINGS AND THE CABLE DID NOT DETECT AN RSO2 NUMBER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071168 ↗
• MalfunctionMay 22, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT THE UNIT EXHIBITED LOW RSO2 READINGS, WITH A BASELINE OF 58 OR A 20% DECREASE FROM THE EXPECTED BASELINE. DURING CEREBRAL PERFUSION MONITORING UNDER ALR AND SEDATION, APPROXIMATELY 30 MINUTES AFTER CLAMPING THE CAROTID ARTERY, THE SENSOR ON THE RIGHT SIDE DISPLAYED AN UNEXPLAINED DROP IN VALUES, SUGGESTING CEREBRAL HYPOPERFUSION. HOWEVER, NO CLINICAL CHANGES WAS OBSERVED. THE ISSUE WAS RESOLVED BY REPLACING THE SENSOR. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070129 ↗
• MalfunctionMay 22, 2025Failure to Analyze Signal; Communication or Transmission Problem; Material Split, Cut or Torn; Failure to Analyze Signal; Communication or Transmission Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD NO RSO2 READINGS AND THE CABLE DID NOT DETECT AN RSO2 NUMBER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069672 ↗
• MalfunctionMay 22, 2025Failure to Analyze Signal; Communication or Transmission Problem; Material Split, Cut or Torn; Failure to Analyze Signal; Communication or Transmission Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD NO RSO2 READINGS AND THE CABLE DID NOT DETECT AN RSO2 NUMBER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069611 ↗
• MalfunctionMay 21, 2025Failure to Analyze Signal; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS NO READING WITH MONITOR AND MALFUNCTION WAS DETECTED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22065840 ↗
• MalfunctionMay 21, 2025Failure to Analyze Signal; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CABLE HAD NO RSO2 READING. IT DID NOT SEND ANY SIGNAL TO THE MONITOR. IT WAS TESTED VIA THE FIELD TEST DEVICE OF THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22065511 ↗
• MalfunctionMay 21, 2025Failure to Analyze Signal; Communication or Transmission Problem; Manufacturing, Packaging or Shipping Problem; Failure to Analyze Signal; Communication or Transmission Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CABLE DID NOT WORK OUT OF THE BOX DURING INSTALLATION. THE CABLE WAS ISSUED ON 1.0 SOFTWARE INSTEAD OF 2. AFTER CHECKING ALL MONITORS AND PRE-AMPS, IT WAS NOTED THAT THE LOT WAS PART OF AFFECTED PRODUCTS AND DID NOT WORK OUT OF THE BOX. WHEN THE CABLE WAS ATTACHED, THERE WERE NO READINGS AND GAVE AN ERROR THAT STATED TO REPLACE SENSOR. THE SENSOR WAS REPLACED, THE PRE AMP-WAS SWAPPED, AND THE CABLE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062464 ↗

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