Curaplex AF2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00812277037029), received between Dec 21, 2023 and Jul 21, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 11, 2023Open, Classified

   A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

   Z-0368-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2026Inflation Problem

  IT WAS REPORTED, THE ITEM WAS RECEIVED WITH A DEFLATED MASK, (BAG VALVE MASK (BVM)), WHICH CAUSED A SERIOUS (UNSPECIFIED) ISSUE WHEN THEY ATTEMPTED TO USE IT DURING A CARDIAC ARREST "[EVENT]". NO ADDITIONAL INFORMATION PROVIDED CONCERNING THE REPORTED EVENT, INCLUDING PATIENT OUTCOME; ADDITIONALLY, THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25897589 ↗
• MalfunctionApr 8, 2026Component Missing

  IT WAS REPORTED THAT DURING A CARDIAC ARREST RESPONSE ON (B)(6) 2026, A PARAMEDIC NOTED THE POP OFF VALVE WAS MISSING WHEN THEY RETRIEVED THE FIRST BAG VALVE MASK (BVM). THE PARAMEDIC IMMEDIATELY SWITCHED TO ANOTHER BVM FROM AVAILABLE STOCK AND WAS ABLE TO COMPLETE THE CALL WITHOUT ISSUE. THERE WERE NO REPORTS OF HARM OR INJURY RESULTING FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818800 ↗
• InjuryNov 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE DEVICE EXPERIENCED A MALFUNCTION THAT INHIBITED PROPER VENTILATION OF A PATIENT, SPECIFICALLY, THE POP-OFF VALVE COMPONENT, LOCATED BETWEEN THE BAG AND THE MANOMETER, BECAME DISLODGED FROM THE BAG VALVE MASK (BVM). THERE WAS NO REPORT OF DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23563137 ↗
• MalfunctionOct 7, 2025Break; Break

  IT WAS REPORTED: THE BAG-VALVE-MASK (BVM) HAD A FAILURE ON THE POP OFF VALVE, DURING PATIENT USE, THE WHITE TOP TO THE VALVE BROKE OFF. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23238705 ↗
• InjuryJan 26, 2024Pressure Problem; Pressure Problem

  PATIENT PRESENTATION: AN UNRESPONSIVE PATIENT, SUFFERING FROM A FOUR-STORY FALL, WAS ASSESSED WITH A GLASGOW COMA SCALE (GCS) SCORE OF 5, INDICATIVE OF SEVERE CONSCIOUSNESS IMPAIRMENT. MEDICAL INTERVENTIONS: RAPID SEQUENCE INTUBATION (RSI) WAS PERFORMED TO ESTABLISH AIRWAY PATENCY. THE ENDOTRACHEAL TUBE (ETT) WAS VENTILATED WITH A SMALL ADULT CURAPLEX (2422-BVMPSA) MANUAL RESUSCITATOR WITH A MANOMETER, POSITIVE END-EXPIRATORY PRESSURE (PEEP) VALVE SET AT 15 CMH2O, IN-LINE END-TIDAL CO2 (ETC02) SENSOR AND CONNECTED TO A 15 L/MIN OXYGEN SOURCE.FIC02 ELEVATION ISSUE: WHILE USING THE CURAPLEX MANUAL RESUSCITATOR, THE PATIENT'S FRACTION OF INSPIRED CO2 (FICO2) LEVELS INCREASED UNTIL THE CLINICAL TEAM PLACED THE PATIENT ON A VENTILATOR. THIS INCREASE BEGAN AT 15:56.24 (FIGURE 1) AND PEAKED AT 35 MMHG AT 15:58.03 (FIGURE 2). FICO2 LEVELS FLUCTUATED BETWEEN 20 AND 35 MMHG (FIGURE 3) UNTIL THE PATIENT WAS TRANSITIONED TO AN AMBU MANUAL RESUSCITATOR AT 15:58.46. THE ELEVATION IN FICO2 RESOLVED ONCE THE VENTILATOR WAS INITIATED (FIGURE 4). PRODUCT PROBLEM: SUSPICIONS ARISE THAT THE MANUAL RESUSCITATOR MAY BE THE SOURCE OF THE ABNORMAL FIC02 ELEVATION. THE FIC02 INCREASE POSES A RISK OF HYPERC

  Patient problems: Decreased Level of Consciousness

  MAUDE report 18592413 ↗
• MalfunctionDec 21, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  THE DISK ON THE BOTTOM THAT ACTS AS A ONE-WAY VALVE CAME LOOSE AND WAS FOUND IN THE BAG. FAILURE WAS ON AN AMBULANCE. THE UNIT FAILURE RESULTED IN LACK OF POSITIVE PRESSURE. THE AIRWAY EMT NOTICED THIS AND CHANGED TO ANOTHER UNIT THAT IN FACT OPERATED CORRECTLY. THE ETCO2 IMPROVEMENT WAS DRAMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377722 ↗