Bivona 67SP030Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 15021312000696), received between Aug 10, 2018 and Apr 13, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (14 reports).

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

5 other recalls cover devices cleared under the same FDA submission (K083641, K914088); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-2615-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE IN THE OPERATING ROOM A TRACH WAS PULLED FOR PLACEMENT WHEN THE NURSE NOTICED THE BALLOON WOULD INFLATE ON THE SHAFT PORTION. ANOTHER TRACH WAS PULLED FROM A DIFFERENT LOT NUMBER AND DID NOT INFLATE. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738287 ↗
• MalfunctionApr 13, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE IN THE OPERATING ROOM A TRACH WAS PULLED FOR PLACEMENT WHEN THE NURSE NOTICED THE BALLOON WOULD INFLATE ON THE SHAFT PORTION. ANOTHER TRACH WAS PULLED FROM A DIFFERENT LOT NUMBER AND DID NOT INFLATE. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738148 ↗
• MalfunctionFeb 14, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED WHILE PREPARING THE TRACH TUBE FOR INSERTION, IT WAS DISCOVERED THAT THE CUFF OF 3 TRACHS WERE NOT INFLATING. A NEW TRACH WAS RECEIVED FROM INTENSIVE CARE UNIT (ICU) TO PLACE IN THE PATIENT. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 20 MAY 2021 FOURTH TRACH HAS FAILED DURING PRE-TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376578 ↗
• MalfunctionFeb 13, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHEN PREPARING THE TRACH TUBE FOR INSERTION, IT WAS DISCOVERED THAT THE CUFF OF 3 TRACHS WERE NOT INFLATING. A NEW TRACH WAS RECEIVED FROM INTENSIVE CARE UNIT (ICU) TO PLACE IN THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16364380 ↗
• MalfunctionSep 23, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, THE CUFF WOULD NOT REMAIN INFLATED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15469719 ↗
• MalfunctionSep 17, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A HOSPITAL PRE-TEST, OF A TRACHEOSTOMY TUBE, THE CUFF FAILED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15443207 ↗
• MalfunctionDec 20, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOONS WERE NOT INFLATING WITH SALINE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043169 ↗
• MalfunctionDec 16, 2021Inflation Problem; Inflation Problem

  THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13021825 ↗
• MalfunctionDec 15, 2021Inflation Problem; Inflation Problem

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL AND ATTACHED 10FEB2022. NO PATIENT INVOLVEMENT. EVENT DETAILS UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014426 ↗
• MalfunctionMar 12, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF COMPONENT OF THE BIVONA TRACHEOSTOMY WAS NOT INFLATING. THIS MALFUNCTION WAS OBSERVED AS THE HEALTHCARE PROFESSIONAL WAS ATTEMPTING TO PLACE THE TRACHEOSTOMY TUBE DURING SURGERY. A REPLACEMENT TRACHEOSTOMY TUBE WAS SUCCESSFULLY USED ON THE PATIENT WHO WAS UNDER ANESTHESIA. NO HARM OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11473590 ↗
• MalfunctionDec 3, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF COMPONENT OF THE BIVONA TRACHEOSTOMY TUBE FAILED TO INFLATE. THIS PRODUCT PROBLEM WAS OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10938275 ↗
• MalfunctionDec 2, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF COMPONENT OF THE BIVONA TRACHEOSTOMY TUBE FAILED TO INFLATE. THIS PRODUCT PROBLEM WAS OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10935937 ↗
• MalfunctionDec 2, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF COMPONENT OF THE BIVONA TRACHEOSTOMY TUBE FAILED TO INFLATE. THIS PRODUCT PROBLEM WAS OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10935731 ↗
• MalfunctionAug 14, 2018Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT DURING TESTING THE BALLOON TO A SMITHS MEDICAL PORTEX® BIVONA® TTS¿ TRACHEOSTOMY TUBE WOULD NOT INFLATE. IT WAS NOTED THAT THE CUFF WAS ATTEMPTED TO MANIPULATE THE CUFF AND THAT IT WAS PARTIALLY FILLED. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7782183 ↗
• MalfunctionAug 10, 2018Defective Component; Defective Component

  INFORMATION WAS RECEIVED THAT THE BIVONA TRACHEOSTOMY TUBE WOULD NOT INFLATE AS THEY PREPARED FOR USE. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7774578 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K914088. One submission often covers many models, so check the product and lot details in each record.

• Z-0205-2024 · Aug 22, 2023 · Open, Classified
  Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
• Z-2946-2020 · Aug 28, 2020 · Terminated
  Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to
• Z-1465-2017 · Feb 9, 2017 · Terminated
  Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
• Z-0930-05 · Apr 26, 2005 · Terminated
  Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
• Z-0302-06 · Feb 17, 2005 · Terminated
  Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.