DreamStation 15MM Heated TubeRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00606959022331), received between Apr 24, 2025 and Jun 29, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (3 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 18, 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.

• MalfunctionJun 29, 2026Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF VISIBLE FOAM PARTICLES WAS FOUND INSIDE THE BLOWER KIT. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DUST FAIL CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25658816 ↗
• MalfunctionJun 10, 2026Thermal Decomposition of Device; Excessive Heating

  THE MANUFACTURER RECEIVED AN INFORMATION ALLEGING THAT 15MM HEATED TUBE HAS A BLACK MARK WHICH LOOKS LIKE A BURNED PLASTIC INSIDE THE TUBING MATERIAL. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465138 ↗
• MalfunctionApr 22, 2026Excessive Heating

  THE DEVICE WAS RECEIVED AND EVALUATED BY THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL). THE 15MM HEATED TUBE RETURNED IN AN OPENED SHIPPING PACKAGING AND COULD OBSERVE A DAMAGED COIL WIRE (PLASTIC ON WIRE LOOKING AS IF IT WAS MELTED). THE PLASTIC TUBING WAS NOT DAMAGED. PIL COULD DETERMINE THE REST OF THE TUBING WAS DAMAGE AND DEFECT FREE AND STILL IN A NORMAL DESIGN ORIENTATION AS INTENDED. PIL CONFIRMED THE COMPLAINT OF ¿BROKEN/PIERCED/EXPOSED HEATING WIRES¿ AND COULD NOT DETERMINE THE CAUSE FOR THE COMPLAINT. PIL COULD CONCLUDE THAT BASED ON THE CAUSE DETERMINATION FOR THE COMPLAINT, NO FURTHER CORRECTIVE ACTION IS REQUIRED FOR THIS COMPLAINT. NO FURTHER INVESTIGATION IS NEEDED. THE 15MM HEATED TUBE HAS BEEN SCRAPPED PER THE REQUIREMENTS SET FORTH IN WORK INSTRUCTION 8.4-1131 REVISION 10 AND DISPOSED OF ACCORDINGLY. NO FURTHER INVESTIGATION WILL BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956441 ↗
• MalfunctionApr 24, 2025Excessive Heating; Excessive Heating

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING HEATED TUBING. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901687 ↗