INVOS PMAC71RSCRecalls & reported problems

Covidien LP · Reusable Sensor Cable for PM7100 · Class 2

All models of INVOS (35)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This is the Covidien INVOS reusable sensor cable, used with a monitor that measures tissue oxygen levels. The 67 reports are all malfunctions, mostly describing cables that failed to produce or send readings, with no deaths and no injuries. There is one open recall, started in January 2024, over manufacturing defects in cable connectors that can cause error codes. Reports fell from 61 in the earlier 12-month period to none in the most recent 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 67
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10884521780125), received between Jun 30, 2022 and May 22, 2025 — classified as 67 malfunctions.

The most frequently reported specific device problem is “Failure to Analyze Signal” (31 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

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 ↗

Most reported problems

Device problems

Failure to Analyze Signal31
Communication or Transmission Problem20
Manufacturing, Packaging or Shipping Problem19
Image Display Error/Artifact16
Low Readings14
Defective Device11
Erratic or Intermittent Display6
Device Alarm System5

Patient problems

No Clinical Signs, Symptoms or Conditions61
Insufficient Information6

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

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, 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 ↗
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 22062453 ↗
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 22062436 ↗
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 22062400 ↗
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 22062350 ↗
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 22062344 ↗
MalfunctionMay 21, 2025Image Display Error/Artifact; Image Display Error/Artifact
ACCORDING TO THE REPORTER, DURING SERVICING, ERROR MESSAGES WERE APPEARING ON THE MONITOR. "REPLACE CABLES" AND "REPLACE SENSORS" WERE THE ERROR MESSAGES THAT APPEARED ON THE PRODUCT'S SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061684 ↗
MalfunctionMay 21, 2025Image Display Error/Artifact; Image Display Error/Artifact
ACCORDING TO THE REPORTER, DURING SERVICING, ERROR MESSAGES WERE APPEARING ON THE MONITOR. "REPLACE CABLES" AND "REPLACE SENSORS" WERE THE ERROR MESSAGES THAT APPEARED ON THE PRODUCT'S SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061676 ↗
MalfunctionMay 21, 2025Image Display Error/Artifact; Image Display Error/Artifact
ACCORDING TO THE REPORTER, DURING SERVICING, ERROR MESSAGES WERE APPEARING ON THE MONITOR. "REPLACE CABLES" AND "REPLACE SENSORS" WERE THE ERROR MESSAGES THAT APPEARED ON THE PRODUCT'S SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061662 ↗
MalfunctionMay 21, 2025Image Display Error/Artifact; Defective Device; Communication or Transmission Problem; Manufacturing, Packaging or Shipping Problem; Image Display Error/Artifact; Defective Device; Communication or Transmission Problem; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS SHOWING NO SENSOR AND NO CABLE ERROR STRAIGHT OUT OF THE BOX. THE FAILURE WAS ISOLATED TO THE DEVICE THROUGH SWAPPING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061657 ↗
MalfunctionMay 21, 2025Image Display Error/Artifact; Defective Device; Communication or Transmission Problem; Manufacturing, Packaging or Shipping Problem; Image Display Error/Artifact; Defective Device; Communication or Transmission Problem; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS SHOWING NO SENSOR AND NO CABLE ERROR STRAIGHT OUT OF THE BOX. THE FAILURE WAS ISOLATED TO THE DEVICE THROUGH SWAPPING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061646 ↗
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 22061630 ↗
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 22061501 ↗
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 22061497 ↗
MalfunctionMay 21, 2025Failure to Analyze Signal; Failure to Analyze Signal
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD NO READING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061476 ↗
MalfunctionMay 21, 2025Image Display Error/Artifact; Image Display Error/Artifact
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT WAS DEFECTIVE AND HAD A SENSOR ERROR INDICATING THE SENSOR WAS NOT ATTACHED. THE UNIT WAS POWER CYCLED AND THE CABLES WERE SWITCHED FOR TROUBLESHOOTING THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061464 ↗
MalfunctionMay 21, 2025Failure to Analyze Signal; Failure to Analyze Signal
ACCORDING TO THE REPORTER, THE CABLES HAD INTERMITTENT SIGNAL ACQUISITION. ALL CABLES WERE CHECKED. EACH CABLE WOULD HAVE A SIGNAL AND THEN AN ERROR WOULD COME UP TO CHECK THE SENSOR. SOMETIMES, THE NUMBER WOULD BE IN THE "LOW TEENS," BUT IT WOULD SPIN FOR A BASELINE. IT WOULD THEN GIVE A BASELINE AND WHEN THE SENSORS WERE CHECKED, IT DID NOT PROVIDE A NUMBER ANYMORE. THE MONITOR, PREAMPLIFIER, SENSOR, AND CABLES WERE SWAPPED, AND THE ISSUES WERE ISOLATED TO THE CABLES. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061340 ↗
MalfunctionMay 21, 2025Failure to Analyze Signal; Failure to Analyze Signal
ACCORDING TO THE REPORTER, DURING USE, CABLE HAD NO READINGS OR LOW READINGS. CHECKED ALL CABLES AND EACH ONE HAD A SIGNAL AND THEN ERROR CODE WILL COME UP TO CHECKED SENSOR. UNIT HAD NUMBER IN LOW TEENS, BUT MOSTLY THEY WILL SPIN FOR BASELINE AND WOULD GIVE THE BASELINE AND THEN SAY CHECK SENSOR AND DID NOT PROVIDE A NUMBER ANYMORE. HAVE ANOTHER CABLES WITH 2022 DATES AND TOOK ALL OF THOSE OUT OF SERVICE. SWAPPED SENSOR AND CABLES TO ISOLATE THE ISSUE. TRIED DIFFERENT MONITOR AND PRE-AMPS AND HAD INTERMITTENT SIGNAL. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061323 ↗
MalfunctionMay 21, 2025Image Display Error/Artifact; Defective Device; Manufacturing, Packaging or Shipping Problem; Image Display Error/Artifact; Defective Device; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE PRODUCT FAILED OUT OF THE BOX AND GAVE A NO CABLE/NO SENSOR ERROR. THE RSC CABLE WAS NOT WORKING. SWAPPING WAS DONE TO ISOLATE THE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061311 ↗
MalfunctionMay 21, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
ACCORDING TO THE REPORTER, THE CABLE HAD INTERMITTENT SIGNAL ACQUISITION. THE CABLE WOULD HAVE A SIGNAL AND THEN AN ERROR WOULD COME UP TO CHECK THE SENSOR. SOMETIMES, THE NUMBER WOULD BE IN THE "LOW TEENS ," BUT IT WOULD SPIN FOR A BASELINE. IT WOULD THEN GIVE A BASELINE AND WHEN THE SENSORS WERE CHECKED, IT DID NOT PROVIDE A NUMBER ANYMORE. THE MONITOR, PREAMPLIFIER, SENSOR, AND CABLES WERE SWAPPED, AND THE ISSUES WERE ISOLATED TO THE CABLE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061254 ↗

Device details

UDI-DI	`10884521780125`
Brand	INVOS
Model	PMAC71RSC
Company	Covidien LP
Product code	MUD · Oximeter, tissue saturation
Class	Class 2
FDA submission	K182868
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Jun 24, 2025

Device type (GMDN): Electrical-only medical device connection cable, reusable

A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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