Nellcor PEDICAPRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20884521083919), received between May 11, 2022 and Apr 29, 2025 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K203762, K944400); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE TWO UNITS WERE GETTING "STUCK" IN THE AMBU BAGS, INDICATING A DIMENSIONAL ISSUE. THE UNITS WOULD NOT FIT SNUGGLY WITHOUT FORCE. ONCE FORCED, IT CAUSES ISSUES WHEN TRIED TO DISCONNECT. THE EVENT TOOK PLACE IN A HOSPITAL SETTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930672 ↗
• MalfunctionApr 29, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE TWO UNITS WERE GETTING "STUCK" IN THE AMBU BAGS, INDICATING A DIMENSIONAL ISSUE. THE EVENT TOOK PLACE IN A HOSPITAL SETTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930661 ↗
• InjuryJun 19, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WERE TWO CARBON DIOXIDE DETECTORS (CO2 DETECTORS) THAT DID NOT CHANGE COLOR AFTER TRACHEAL INTUBATION. THE CO2 DETECTOR WAS PLACED AT THE END OF THE TUBE, AND NO COLOR CHANGE WAS NOTED FROM PURPLE TO YELLOW. ANOTHER CO2 DETECTOR WAS OPENED AND PLACED AGAIN, AND STILL NO COLOR CHANGE WAS NOTED. MULTIPLE ADJUSTMENTS TO THE DEPTH OF THE TUBE WERE MADE TO SEE IF IT WOULD CORRECT THE ISSUE. THIS RESULTED IN THE INFANT BEING ELECTIVELY EXTUBATED DESPITE CLINICAL SIGNS OF INTUBATION. IT WAS ALSO REPORTED THAT THE PATIENT HAD SERIOUS INJURY.

  Patient problems: Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 19570578 ↗
• InjuryJun 19, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WERE TWO CARBON DIOXIDE DETECTORS (CO2 DETECTORS) THAT DID NOT CHANGE COLOR AFTER TRACHEAL INTUBATION. THE CO2 DETECTOR WAS PLACED AT THE END OF THE TUBE, AND NO COLOR CHANGE WAS NOTED FROM PURPLE TO YELLOW. ANOTHER CO2 DETECTOR WAS OPENED AND PLACED AGAIN, AND STILL NO COLOR CHANGE WAS NOTED. MULTIPLE ADJUSTMENTS TO THE DEPTH OF THE TUBE WERE MADE TO SEE IF IT WOULD CORRECT THE ISSUE. THIS RESULTED IN THE INFANT BEING ELECTIVELY EXTUBATED DESPITE CLINICAL SIGNS OF INTUBATION. IT WAS ALSO REPORTED THAT THE PATIENT HAD SERIOUS INJURY.

  Patient problems: Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 19570557 ↗
• MalfunctionApr 22, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE TWO REPORTED DEVICES WERE NOT FITTING PROPERLY TO THE CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154376 ↗
• MalfunctionApr 22, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE TWO REPORTED DEVICES WERE NOT FITTING PROPERLY TO THE CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154361 ↗
• MalfunctionJul 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACHEAL TUBE CONNECTOR PART OF THE DEVICE WAS DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17354068 ↗
• MalfunctionJun 16, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  ACCORDING TO THE REPORTER, THE CO2 DETECTORS DID NOT CHANGE COLOR, WHICH INDICATES THE INCORRECT PLACEMENT OF THE ENDOTRACHEAL TUBE. AS A RESULT, THE PATIENT WAS REINTUBATED UNNECESSARILY, AND AN ALTERNATIVE MEANS OF DETECTION DETERMINED THAT THE ENDOTRACHEAL TUBE WAS PLACED CORRECTLY.

  Patient problems: Unintended Extubation

  MAUDE report 17143200 ↗
• MalfunctionMay 24, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  ACCORDING TO THE REPORTER, THREE CO2 DETECTORS DID NOT CHANGE COLOR, WHICH INDICATES THE INCORRECT PLACEMENT OF THE ENDOTRACHEAL TUBE. AS A RESULT, THE PATIENT WAS REINTUBATED UNNECESSARILY, AND AN ALTERNATIVE MEANS OF DETECTION DETERMINED THAT THE ENDOTRACHEAL TUBE WAS PLACED CORRECTLY.

  Patient problems: Unintended Extubation

  MAUDE report 16993554 ↗
• MalfunctionMay 24, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  ACCORDING TO THE REPORTER, THREE CO2 DETECTORS DID NOT CHANGE COLOR, WHICH INDICATES THE INCORRECT PLACEMENT OF THE ENDOTRACHEAL TUBE. AS A RESULT, THE PATIENT WAS REINTUBATED UNNECESSARILY, AND AN ALTERNATIVE MEANS OF DETECTION DETERMINED THAT THE ENDOTRACHEAL TUBE WAS PLACED CORRECTLY.

  Patient problems: Unintended Extubation

  MAUDE report 16992821 ↗
• MalfunctionMay 24, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  ACCORDING TO THE REPORTER, THREE CO2 DETECTORS DID NOT CHANGE COLOR, WHICH INDICATES THE INCORRECT PLACEMENT OF THE ENDOTRACHEAL TUBE. AS A RESULT, THE PATIENT WAS REINTUBATED UNNECESSARILY, AND AN ALTERNATIVE MEANS OF DETECTION DETERMINED THAT THE ENDOTRACHEAL TUBE WAS PLACED CORRECTLY.

  Patient problems: Unintended Extubation

  MAUDE report 16992820 ↗
• MalfunctionOct 21, 2022Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  ACCORDING TO THE REPORTER, THE DEVICE DID NOT GIVE ANY COLOR CHANGE, WHICH WAS CONFIRMED FAILURE FROM AN INTUBATED PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15652595 ↗
• MalfunctionOct 21, 2022Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE INITIALLY GAVE A SLIGHT CHANGE TO PURPLE THEN IT SEEMED TO NOT CHANGE ANY FURTHER IN AN INTUBATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15652279 ↗
• MalfunctionMay 11, 2022Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  ACCORDING TO THE REPORTER, AFTER TRACHEAL INTUBATION, THE DEVICE'S COLOR DID NOT CHANGE FROM PURPLE TO YELLOW. WHEN AN X-RAY WAS TAKEN, IT WAS CONFIRMED THAT IT WAS INTUBATED IN THE TRACHEA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14364413 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203762, K944400. One submission often covers many models, so check the product and lot details in each record.

• Z-2047-2009 · Aug 14, 2009 · Terminated
  Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. Sold in packages of 6 (PediCap6) or 24 (PediC