Bivona 67PFPS40Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10351688518545), received between Sep 14, 2022 and Apr 1, 2025 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K923878); they may or may not involve this specific model.

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. May 29, 2024Open, Classified

   Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

   Z-2612-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE AND/OR INFLATE ON BOTH SIDES. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748528 ↗
• MalfunctionFeb 6, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT NEITHER OF THE BALLOONS WOULD INFLATE WHEN IN USE. THERE WERE NO PATIENT HARM OR ADVERSE EVENT REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21329082 ↗
• MalfunctionFeb 6, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT NEITHER OF THE BALLOONS WOULD INFLATE WHEN IN USE AND WOULD NOT HOLD ANYTHING. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21328997 ↗
• MalfunctionDec 13, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF BALLOON DID NOT INFLATE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925628 ↗
• MalfunctionNov 20, 2024Burst Container or Vessel; Gas/Air Leak; Burst Container or Vessel; Gas/Air Leak

  IT WAS REPORTED THAT THE BALLOON WAS LEAKING, AND THE BALLOON POPPED. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT HOME. THERE WAS NO MEDICAL INTERVENTION REQUIRED, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737307 ↗
• MalfunctionNov 14, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON ON THE TRACH WILL NOT INFLATE. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683071 ↗
• InjuryJan 24, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED AN ISSUE WITH SOME TRACHS LAST WEEK. THE PATIENT NEEDED TRACH CHANGES THREE TIMES IN THREE DIFFERENT SHIFTS DUE TO CUFF LEAKS. THE PATIENT'S TRACH MUST BE ORDERED. THE PATIENT ONCE NEEDED A STANDARD LENGTH TO BE PLACED WHILE WAITED FOR MORE PLUS LENGTHS TO COME. THE REGULAR LENGTH POSED NO PROBLEMS. PATIENT HAS UNDERGONE FOUR SEPARATE TRACH CHANGES AND FOUR MALFUNCTIONING CUFFS IN TOTAL. OUTCOME OF THE EVENT WAS-RESOLVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234581 ↗
• InjuryJan 24, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED AN ISSUE WITH SOME TRACHS LAST WEEK. THE PATIENT NEEDED TRACH CHANGES THREE TIMES IN THREE DIFFERENT SHIFTS DUE TO CUFF LEAKS. THE PATIENT'S TRACH MUST BE ORDERED. THE PATIENT ONCE NEEDED A STANDARD LENGTH TO BE PLACED WHILE WAITED FOR MORE PLUS LENGTHS TO COME. THE REGULAR LENGTH POSED NO PROBLEMS. PATIENT HAS UNDERGONE FOUR SEPARATE TRACH CHANGES AND FOUR MALFUNCTIONING CUFFS IN TOTAL. OUTCOME OF THE EVENT WAS-RESOLVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234567 ↗
• InjuryJan 24, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED AN ISSUE WITH SOME TRACHS LAST WEEK. THE PATIENT NEEDED TRACH CHANGES THREE TIMES IN THREE DIFFERENT SHIFTS DUE TO CUFF LEAKS. THE PATIENT'S TRACH MUST BE ORDERED. THE PATIENT ONCE NEEDED A STANDARD LENGTH TO BE PLACED WHILE WAITED FOR MORE PLUS LENGTHS TO COME. THE REGULAR LENGTH POSED NO PROBLEMS. PATIENT HAS UNDERGONE FOUR SEPARATE TRACH CHANGES AND FOUR MALFUNCTIONING CUFFS IN TOTAL. OUTCOME OF THE EVENT WAS-RESOLVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234541 ↗
• InjuryJan 23, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED AN ISSUE WITH SOME TRACHS LAST WEEK. THE PATIENT NEEDED TRACH CHANGES THREE TIMES IN THREE DIFFERENT SHIFTS DUE TO CUFF LEAKS. THE PATIENT'S TRACH MUST BE ORDERED. THE PATIENT ONCE NEEDED A STANDARD LENGTH TO BE PLACED WHILE WAITED FOR MORE PLUS LENGTHS TO COME. THE REGULAR LENGTH POSED NO PROBLEMS. PATIENT HAS UNDERGONE FOUR SEPARATE TRACH CHANGES AND FOUR MALFUNCTIONING CUFFS IN TOTAL. OUTCOME OF THE EVENT WAS-RESOLVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16230254 ↗
• MalfunctionSep 14, 2022Inflation Problem; Tear, Rip or Hole in Device Packaging; Inflation Problem; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TWO TRACHS WITH ISSUES. ONE TRACH CUFF HAS A HOLE AND ANOTHER CUFF WAS INFLATING ASYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417038 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923878. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2007 · Nov 17, 2006 · Terminated
  Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.