INVOS PMSENS71-PRecalls & reported problems
Covidien LP · Pediatric rSO2 Sensor · Class 2
All models of INVOS (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521807433), received between Nov 18, 2024 and Nov 18, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Erratic or Intermittent Display” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K182868, K211561); 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.
Reports received per month
Most reported problems
Device problems
- Erratic or Intermittent Display1
- High Readings1
- Low Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2024Erratic or Intermittent Display; High Readings; Low Readings; Erratic or Intermittent Display; High Readings; Low Readings
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD AN ERRATIC SPO2 (PERIPHERAL OXYGEN SATURATION) READING, RSO2 (REGIONAL OXYGEN SATURATION) VALUE WERE LOW 0 AND HIGH 60,70 AND 80. 2 CHANNELS WERE IN USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20708603 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K182868, K211561. One submission often covers many models, so check the product and lot details in each record.
- Z-1732-2024 · Jan 9, 2024 · Open, ClassifiedMedtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
- Z-1731-2024 · Jan 9, 2024 · Open, ClassifiedMedtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Other Oximeter, tissue saturation devices
- INVOS PMAC71RSCCovidien LP · Oximeter, tissue saturation1 recall67 reports
- HEMOSPHERE FORESIGHT MODULE HEMFSM10Edwards Lifesciences LLC · Oximeter, Tissue Saturation1 recall12 reports
- INVOS PMAC71RICCovidien LP · Oximeter, tissue saturation1 recall4 reports
- FORE-SIGHT ELITE® 01-06-3000Cas Medical Systems, Inc. · Oximeter, Tissue Saturation1 recall1 death2 reports
- Invos 5100C-EUCovidien LP · Oximeter, tissue saturation22 reports
- INVOS PM7100Covidien LP · Oximeter, tissue saturation21 reports
- INVOS PM7100Covidien LP · Oximeter, tissue saturation18 reports
- INVOS 5100C-PACovidien LP · Oximeter, tissue saturation15 reports
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
- 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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