F&P FlexiTrunkRecalls & reported problems across all models
Fisher & Paykel Healthcare Limited · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 121
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 6 models of F&P FlexiTrunk by Fisher & Paykel Healthcare Limited in the FDA's device registry (GUDID). Together they are named in 121 adverse event reports in the FDA's MAUDE database, received between Feb 5, 2018 and Sep 29, 2026 — classified as 121 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (74 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported F&P FlexiTrunk problems
Device problems
- Material Split, Cut or Torn74
- Break28
- Gas/Air Leak22
- Detachment of Device or Device Component6
- Fluid/Blood Leak3
- Leak/Splash2
- Device Damaged Prior to Use1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions115
- Low Oxygen Saturation5
- No Patient Involvement2
- No Information1
F&P FlexiTrunk models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- F&P FlexiTrunk BC191-05Set, Tubing And Support, Ventilator (W Harness)76 reports
- F&P FlexiTrunk BC190-05Set, Tubing And Support, Ventilator (W Harness)26 reports
- F&P FlexiTrunk BC192-05Set, Tubing And Support, Ventilator (W Harness)12 reports
- F&P FlexiTrunk BC801-10Mask, Oxygen4 reports
- F&P FlexiTrunk BC802-10Mask, Oxygen2 reports
- F&P FlexiTrunk BC803-10Mask, Oxygen1 report
Recent F&P FlexiTrunk adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938900 ↗MalfunctionSep 21, 2026Gas/Air Leak; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849337 ↗MalfunctionSep 1, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554041 ↗MalfunctionAug 27, 2026Gas/Air Leak; Material Split, Cut or Torn
A healthcare facility in (b)(6) reported that the a BC191-05 FlexiTrunk Nasal Tubing torn during use. It was further reported that the device was replaced. There were no reported patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50467019 ↗MalfunctionJul 5, 2026Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CALIFORNIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF SIX BC191-05 FLEXITRUNK NASAL TUBING WERE FAILING DUE TO PINHOLE LEAKS OR TEARS. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25713113 ↗MalfunctionMay 26, 2026Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED VIA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REPORTING SYSTEM THAT THE TUBING OF A BC191-05 FLEXITRUNK NASAL TUBING WAS DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25295606 ↗MalfunctionMay 15, 2026Break
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF A BC191-05 FLEXITRUNK NASAL TUBING WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179881 ↗MalfunctionMay 1, 2026Break
A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF A BC191- 05 FLEXITRUNK NASAL TUBING WAS FOUND BROKEN BEFORE BEING USED ON A PATIENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25053997 ↗MalfunctionApr 22, 2026Gas/Air Leak; Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF A BC190-05 FLEXITRUNK NASAL TUBING WAS BROKEN AND RESULTED IN LEAK DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24952074 ↗MalfunctionApr 21, 2026Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF A BC191-05 FLEXITRUNK NASAL TUBING WAS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948334 ↗MalfunctionApr 2, 2026Fluid/Blood Leak; Gas/Air Leak
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE BC191-05 FLEXITRUNK NASAL TUBING WAS LEAKING DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24764823 ↗MalfunctionApr 2, 2026Material Split, Cut or Torn
A HEALTHCARE FACILITY IN BELGIUM REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF A BC191-05 FLEXITRUNK NASAL TUBING WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24764544 ↗MalfunctionApr 1, 2026Gas/Air Leak
A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A LEAK WAS IDENTIFIED WHILE USING A BC191-05 FLEXITRUNK NASAL TUBING. IT WAS FURTHER REPORTED THAT TWO OTHER UNITS WERE AFFECTED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24761328 ↗MalfunctionApr 1, 2026Leak/Splash; Gas/Air Leak
A HEALTHCARE FACILITY IN (B)(6) HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A BC191-05 FLEXITRUNK NASAL TUBING WAS FOUND LEAKING AT THE CONNECTOR. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754294 ↗MalfunctionMar 31, 2026Gas/Air Leak
A HEALTHCARE FACILITY IN WEST VIRGINIA HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE A BC191-05 FLEXITRUNK NASAL TUBING WAS FOUND LEAKING AT THE CONNECTOR. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24750338 ↗
Other Fisher & Paykel Healthcare Limited products
All Fisher & Paykel Healthcare Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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