ErgoStar CM 55 MP01855Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04048675042655), received between Jun 11, 2025 and Jun 17, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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. Nov 10, 2025Open, Classified

   Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

   Z-0592-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Fracture; Material Puncture/Hole; Gas/Air Leak; Fracture; Material Puncture/Hole; Gas/Air Leak

  IN THE USER FACILITY REPORT RELATING TO COMPLAINT (B)(4) (MDR REPORT NO. 9611500-2025-00297), WE WERE INFORMED THAT THE MEMBRANE OF THE ERGOSTAR CM55 HAD RUPTURED IN 9 FURTHER CASES SO THAT REPORTEDLY DUE TO THE LEAK THE PATIENT COULD NO LONGER BE VENTILATED ADEQUATELY. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22221100 ↗
• MalfunctionJun 17, 2025Fracture; Material Puncture/Hole; Gas/Air Leak; Fracture; Material Puncture/Hole; Gas/Air Leak

  IN THE USER FACILITY REPORT RELATING TO COMPLAINT (B)(4) (MDR REPORT NO. 9611500-2025-00297), WE WERE INFORMED THAT THE MEMBRANE OF THE ERGOSTAR CM55 HAD RUPTURED IN 9 FURTHER CASES SO THAT REPORTEDLY DUE TO THE LEAK THE PATIENT COULD NO LONGER BE VENTILATED ADEQUATELY. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22221093 ↗
• MalfunctionJun 17, 2025Fracture; Material Puncture/Hole; Gas/Air Leak; Fracture; Material Puncture/Hole; Gas/Air Leak

  IN THE USER FACILITY REPORT RELATING TO COMPLAINT (B)(4) (MDR REPORT NO. 9611500-2025-00297), WE WERE INFORMED THAT THE MEMBRANE OF THE ERGOSTAR CM55 HAD RUPTURED IN 9 FURTHER CASES SO THAT REPORTEDLY DUE TO THE LEAK THE PATIENT COULD NO LONGER BE VENTILATED ADEQUATELY. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22221092 ↗
• MalfunctionJun 17, 2025Fracture; Material Puncture/Hole; Gas/Air Leak; Fracture; Material Puncture/Hole; Gas/Air Leak

  IN THE USER FACILITY REPORT RELATING TO COMPLAINT (B)(4) (MDR REPORT NO. 9611500-2025-00297), WE WERE INFORMED THAT THE MEMBRANE OF THE ERGOSTAR CM55 HAD RUPTURED IN 9 FURTHER CASES SO THAT REPORTEDLY DUE TO THE LEAK THE PATIENT COULD NO LONGER BE VENTILATED ADEQUATELY. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22221069 ↗
• MalfunctionJun 17, 2025Fracture; Material Puncture/Hole; Gas/Air Leak; Fracture; Material Puncture/Hole; Gas/Air Leak

  IN THE USER FACILITY REPORT RELATING TO COMPLAINT (B)(4) (MDR REPORT NO. 9611500-2025-00297), WE WERE INFORMED THAT THE MEMBRANE OF THE ERGOSTAR CM55 HAD RUPTURED IN 9 FURTHER CASES SO THAT REPORTEDLY DUE TO THE LEAK THE PATIENT COULD NO LONGER BE VENTILATED ADEQUATELY. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22221037 ↗
• MalfunctionJun 17, 2025Fracture; Material Puncture/Hole; Gas/Air Leak; Fracture; Material Puncture/Hole; Gas/Air Leak

  IN THE USER FACILITY REPORT RELATING TO COMPLAINT (B)(4) (MDR REPORT NO. 9611500-2025-00297), WE WERE INFORMED THAT THE MEMBRANE OF THE ERGOSTAR CM55 HAD RUPTURED IN 9 FURTHER CASES SO THAT REPORTEDLY DUE TO THE LEAK THE PATIENT COULD NO LONGER BE VENTILATED ADEQUATELY. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22221033 ↗
• MalfunctionJun 17, 2025Fracture; Material Puncture/Hole; Gas/Air Leak; Fracture; Material Puncture/Hole; Gas/Air Leak

  IN THE USER FACILITY REPORT RELATING TO COMPLAINT (B)(4) (MDR REPORT NO. 9611500-2025-00297), WE WERE INFORMED THAT THE MEMBRANE OF THE ERGOSTAR CM55 HAD RUPTURED IN 9 FURTHER CASES SO THAT REPORTEDLY DUE TO THE LEAK THE PATIENT COULD NO LONGER BE VENTILATED ADEQUATELY. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22221031 ↗
• MalfunctionJun 17, 2025Fracture; Material Puncture/Hole; Gas/Air Leak; Fracture; Material Puncture/Hole; Gas/Air Leak

  IN THE USER FACILITY REPORT RELATING TO COMPLAINT (B)(4) (MDR REPORT NO. 9611500-2025-00297), WE WERE INFORMED THAT THE MEMBRANE OF THE ERGOSTAR CM55 HAD RUPTURED IN 9 FURTHER CASES SO THAT REPORTEDLY DUE TO THE LEAK THE PATIENT COULD NO LONGER BE VENTILATED ADEQUATELY. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22221025 ↗
• MalfunctionJun 17, 2025Fracture; Material Puncture/Hole; Gas/Air Leak; Fracture; Material Puncture/Hole; Gas/Air Leak

  IN THE USER FACILITY REPORT RELATING TO COMPLAINT (B)(4), (MDR REPORT NO. 9611500-2025-00297), WE WERE INFORMED THAT THE MEMBRANE OF THE ERGOSTAR CM55 HAD RUPTURED IN 9 FURTHER CASES SO THAT REPORTEDLY DUE TO THE LEAK THE PATIENT COULD NO LONGER BE VENTILATED ADEQUATELY. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22221024 ↗
• MalfunctionJun 11, 2025Fracture; Material Puncture/Hole; Gas/Air Leak; Fracture; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT A PATIENT WAS INDUCED FOR A SURGICAL PROCEDURE IN THE INDUCTION DEPARTMENT WITHOUT ANY SPECIAL INCIDENTS. A PERSEUS WAS USED AS THE ANESTHESIA MACHINE AND A REUSABLE TUBE SYSTEM WITH FILTER, TUBE EXTENSION AND MASK WAS ALSO USED. AFTER INTUBATION, THE PATIENT WAS SWITCHED FROM MANUAL VENTILATION TO PC. THE USER NOTICED THAT THERE WAS A LEAK, WHICH WAS GETTING BIGGER BY THE MINUTE. THE CUSTOMER SUSPECTED THAT THE TUBE WAS THE CAUSE OF THE LEAK AND REINTUBATED THE PATIENT. AFTER REINTUBATION, THE PATIENT WAS TRANSFERRED FROM THE INDUCTION TO THE ROOM AND CONTINUED TO BE VENTILATED ON A PERSEUS IN PC. THE USER REPORTED THAT THE LEAKAGE DETECTED IN THE INDUCTION WAS ALSO PRESENT WITH THE NEW TUBE. AFTER A SHORT TIME, AN AUDIBLE NOISE COULD BE HEARD, WHICH WAS DUE TO A CRACK IN THE ERGOSTAR CM 55. ERGOSTAR WAS REPLACED AND VENTILATION WAS CONTINUED WITHOUT FURTHER INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185408 ↗