Curaplex 301-BVM1500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00812277035322), received between Dec 12, 2025 and Feb 3, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Material Fragmentation

  IT WAS REPORTED THAT A PLASTIC PIECE ON THE BAG VALVE MASK (BVM) BROKE OFF ON SEVERAL OCCASIONS, RENDERING THE DEVICE UNUSABLE. NO DELAY IN THERAPY, HARM, OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246555 ↗
• MalfunctionDec 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A CARDIAC ARREST EVENT, THE BAG VALVE MASK (BVM) BROKE INTO THREE PIECES WHEN REMOVED FROM ITS PACKAGING. THIS IS THE THIRD INSTANCE OBSERVED WHERE BVMS FROM THE CUSTOMER'S STOCK HAVE EXHIBITED THIS ISSUE. THERE WERE NO REPORTS OF HARM, INJURY, OR DELAY IN THERAPY ASSOCIATED WITH THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 1314417-2025-00101 FOR THE FIRST REPORT. REFER TO 1314417-2025-00102 FOR THE SECOND REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790271 ↗
• MalfunctionDec 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A CARDIAC ARREST EVENT, THE BAG VALVE MASK (BVM) BROKE INTO THREE PIECES WHEN REMOVED FROM ITS PACKAGING. THIS IS THE THIRD INSTANCE OBSERVED WHERE BVMS FROM THE CUSTOMER'S STOCK HAVE EXHIBITED THIS ISSUE. THERE WERE NO REPORTS OF HARM, INJURY, OR DELAY IN THERAPY ASSOCIATED WITH THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 1314417-2025-00101 FOR THE FIRST REPORT. REFER TO 1314417-2025-00103 FOR THE THIRD REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790233 ↗
• MalfunctionDec 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A CARDIAC ARREST EVENT, THE BAG VALVE MASK (BVM) BROKE INTO THREE PIECES WHEN REMOVED FROM ITS PACKAGING. THIS IS THE THIRD INSTANCE OBSERVED WHERE BVMS FROM THE CUSTOMER'S STOCK HAVE EXHIBITED THIS ISSUE. THERE WERE NO REPORTS OF HARM, INJURY, OR DELAY IN THERAPY ASSOCIATED WITH THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 1314417-2025-00102 FOR THE SECOND REPORT. REFER TO 1314417-2025-00103 FOR THE THIRD REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790201 ↗