Bivona 60SP040Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 15021312000382), received between Mar 23, 2017 and Dec 3, 2025 — classified as 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

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

46 other recalls cover devices cleared under the same FDA submission (K083641, K912469); 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-2602-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE WINGS TORE ON BOTH TRACHEOSTOMY TUBES. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709806 ↗
• MalfunctionJun 20, 2025Material Puncture/Hole; Material Puncture/Hole

  AN EMAIL WAS RECEIVED REGARDING A 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE 1/EA WITH LIST NUMBER 60SP040 AND LOT NUMBER 6063394. IT WAS STATED THAT THERE WERE HOLES IN THE SHAFT. TRACH WAS SENT TO MDRD FOR REPROCESSING POST TRACH CHANGE ¿ MDRD STAFF NOTICED HOLES PRIOR TO CLEANING TRACH FOR 1ST REPROCESSING IN MDRD. ADDITIONAL INFORMATION RECEIVED AUGUST 21, 2025, WITH UPDATED LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302556 ↗
• InjuryMay 13, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE SLOT HOLDING THE TRACH TIE BROKE AND CAUSED THE PATIENT'S TRACH CAME OUT. THE TRACH TIE WAS STILL ATTACHED BUT EYELET HAS SNAPPED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011369 ↗
• MalfunctionMay 12, 2025Crack; Crack

  IT WAS REPORTED THAT A CRACK WAS FOUND IN THE FLANGE DURING USE. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WERE NO PATIENT HARMS OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006493 ↗
• MalfunctionFeb 18, 2025Crack; Crack

  IT WAS REPORTED THAT A CRACK WAS FOUND IN THE FLANGE DURING USE. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WERE NO PATIENT HARMS OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21406946 ↗
• MalfunctionFeb 3, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE SLOT HOLDING THE TRACH TIE BROKE AND CAUSED THE PATIENT'S TRACH CAME OUT. THE TRACH TIE WAS STILL ATTACHED BUT EYELET HAS SNAPPED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21298102 ↗
• MalfunctionSep 24, 2024Crack; Crack

  IT WAS REPORTED THAT WHEN A PATIENT AT HOME CAME TO THE HOSPITAL TO HAVE THE TUBE REPLACED, WHEN THE TUBE WAS BEING REPLACED, IT WAS DISCOVERED THAT THE FLANGE HAD CRACKED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294513 ↗
• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED THAT WHILE THE TRACH WAS IN PLACE, A SNAPPING SOUND WAS HEARD. IT WAS OBSERVED THAT THE FLANGE GOT DAMAGED. THEY WOULD LIKE TO KNOW WHY THIS ISSUE HAPPENED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869276 ↗
• MalfunctionSep 14, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THE CUSTOMER NOTICED THE FLANGE WAS TORN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418774 ↗
• MalfunctionSep 14, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THE CUSTOMER NOTICED THE FLANGE WAS TORN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417629 ↗
• MalfunctionJun 15, 2022Break; Break

  IT WAS REPORTED THAT THE NEW TRACHEOSTOMY TUBE WAS SECURED IN THE TRACHEAL STOMA OF THE PATIENT WHEN THE LEFT FLANGE BROKE AT THE SECURING PART AND RESULTED IN THE TRACHEOSTOMY TUBE DECANNULATING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691825 ↗
• MalfunctionJun 14, 2022Break; Break

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS SECURED IN THE TRACHEAL STOMA OF THE PATIENT WHEN THE LEFT FLANGE BROKE AT THE SECURING PART AND RESULTED IN THE TRACHEOSTOMY TUBE DECANNULATING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14688912 ↗
• MalfunctionMay 24, 2022Break; Break

  IT WAS REPORTED THAT THE BIVONA TRACHEOSTOMY TUBE WAS INSERTED IN PATIENTS TRACHEOSTOMY STOMA AND THE LEFT FLANGE BROKE AT THE SECURING PART WHICH CAUSED THE TRACHEOSTOMY TUBE TO DECANNULATED .THE PATIENT WAS ABLE TO HOLD THE TUBE IN PLACE AND REPLACE A NEW TUBE IN THE STOMA THIS HAPPENED WITH TWO TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488350 ↗
• MalfunctionMay 24, 2022Break; Break

  IT WAS REPORTED THAT THE BIVONA TRACHEOSTOMY TUBE WAS INSERTED IN PATIENTS TRACHEOSTOMY STOMA AND THE LEFT FLANGE BROKE AT THE SECURING PART WHICH CAUSED THE TRACHEOSTOMY TUBE TO DECANNULATED .THE PATIENT WAS ABLE TO HOLD THE TUBE IN PLACE AND REPLACE A NEW TUBE IN THE STOMA THIS HAPPENED WITH TWO TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488310 ↗
• MalfunctionFeb 9, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE INSIDE OF THE TRACHEOSTOMY TUBE IS NOT SMOOTH. THERE ARE A COUPLE JAGGED-LOOKING BITS THAT CUSTOMER IS WORRIED MAY CAUSE SECRETIONS TO BUILD UP. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497390 ↗
• InjuryOct 21, 2021Crack; Crack

  IT WAS REPORTED THAT 7 DAYS AFTER USING THE DEVICE, THE CUSTOMER FOUND A CRACK IN THE BASE PART OF THE SIDE FLANGE. IT WAS EMERGENTLY CHANGED. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12677594 ↗
• InjuryMay 31, 2018Connection Problem; Connection Problem

  IT WAS REPORTED BY THE PATIENT'S PARENT THAT ON (B)(6) 2018, THE BIVONA TRACHEOSTOMY TUBE SEPARATED FROM THE FLANGE AND APPEARED TO HAVE DISAPPEARED IN THE STOMA. THE PATIENT EXPERIENCED COUGH AND NOISY BREATHING AS A RESULT. THE PARENT BROUGHT THE CHILD TO THE ER. THE CHILD WAS THEN TRANSFERRED TO A (B)(6) FOR BRONCHOSCOPY AND REMOVAL OF THE FOREIGN BODY UNDER ANESTHESIA. THE PATIENT WAS LATER DISCHARGED FROM THE HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 7557775 ↗
• InjuryMar 21, 2018Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT, WHILE IN USE WITH A PATIENT, THE EYELET ON THE FLANGE OF THIS TRACHEOSTOMY TUBE BROKE DURING ROUTINE TIGHTENING OF THE TRACHEOSTOMY TIES. IT WAS NOTED THAT THE MANUFACTURER PROVIDED TWILL TIES WERE BEING USED. THE TRACHEOSTOMY TUBE HAD TO BE REMOVED AND THE PATIENT HAD TO USE THEIR EMERGENCY BACKUP TRACHEOSTOMY TUBE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7357232 ↗
• InjuryNov 30, 2017Break; Difficult to Remove; Break; Difficult to Remove

  THE PATIENT'S PHYSICIAN DESCRIBED THE STOMA TO BE "MILDLY ERYTHEMATOUS". THE PATIENT'S MOTHER REMOVED THE DEFECTIVE SHAFT AND REPLACED WITH A NEW TRACHEOSTOMY TUBE. THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Erythema; Obstruction/Occlusion

  MAUDE report 7072410 ↗
• MalfunctionMar 23, 2017Crack; Material Rupture; Crack; Material Rupture

  IT WAS REPORTED THAT A PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE HAD A CRACK AND RUPTURE IN THE TUBE, LOCATED UNDER THE FLANGE. THE ISSUE WAS OBSERVED BY THE PATIENT'S MOTHER DURING A STANDARD TUBE CHANGE. THE TUBE WAS IN SITU FOR THREE WEEKS BEFORE A CHANGE TOOK PLACE. THE TUBE HAD BEEN REUSED FOR THE FOURTH TIME WHEN THE EVENT OCCURRED. THE TUBE WAS CLEANED AS NOTED IN THE DEVICE'S INSTRUCTIONS FOR USE. A NEW TRACHEOSTOMY TUBE WAS PLACED TO ADDRESS THE ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6427397 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K912469. One submission often covers many models, so check the product and lot details in each record.

• Z-2598-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDI
• Z-2606-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List N
• Z-2613-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOS
• Z-2591-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item
• Z-2588-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0
• Z-2612-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PE
• Z-2611-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC
• Z-2605-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOM
• Z-2607-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
• Z-2589-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RAN
• Z-2615-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL T
• Z-2601-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND
• Z-2608-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEO
• Z-2600-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKSTRAP, Product Code/List Number/Item Code
• Z-2609-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATA

…and 31 more.