Bivona 60P040Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 15021312005752), received between Apr 26, 2017 and Apr 10, 2024 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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-2595-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S TRACH FLANGES WERE STARTING TO TEAR ON BOTH SIDES SO THE TRACH WAS CHANGED BEFORE IT WOULD TEAR ALL THE WAY THROUGH. IT WAS THEN NOTICED THAT THE BACKUP TRACHS ALSO HAD SMALL TEARS ON THEM. THE DEVICES ARE NOT AVAILABLE FOR INVESTIGATION SINCE THEY WERE DISCARDED. THERE WAS A PATIENT INVOLVEMENT BUT UNKNOWN HARM OR ADVERSE EVENT. THERE WAS 1 PATIENT AND 3 PRODUCT FAULTS. EMDR-19024, EMDR-19030 AND EMDR-19031 REPRESENT THE SAME PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19084534 ↗
• MalfunctionApr 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE CA/RN NOTICED A VERY SLIGHT TEAR IN TRACH FLANGES AROUND 0930 DURING DAILY TIE CHANGE. DECISION WAS MADE TO NOT CHANGE THE TRACH AT THAT TIME BECAUSE THE TEAR WAS VERY MINOR. AFTER EVALUATING THE FLANGES THROUGHOUT THE DAY, THE TEAR WAS FOUND TO BE LARGER AROUND 1530. DEVICE IS NOT AVAILABLE FOR INVESTIGATION SINCE IT WAS DISCARDED. THERE WAS A PATIENT INVOLVEMENT BUT UNKNOWN HARM OR ADVERSE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19084467 ↗
• MalfunctionApr 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE TRACH FLANGES HAD TEARS IN THEM. DEVICE IS NOT AVAILABLE FOR INVESTIGATION SINCE THEY WERE DISCARDED. THERE WAS A PATIENT INVOLVEMENT BUT UNKNOWN HARM OR ADVERSE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19084198 ↗
• InjuryApr 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT THERE WERE CRACKS IN THE FLANGE PORTION OF THE TRACH. THE RN WAS CALLED INTO ROOM AFTER FINDING PARTIAL TEARS ON BILATERAL TRACH FLANGES. TO PREVENT COMPLETE TEAR IN FLANGES, THIS RN COMPETED TRACH CHANGE. DEVICE IS NOT AVAILABLE FOR INVESTIGATION SINCE IT WAS DISCARDED. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19084092 ↗
• InjuryApr 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S TRACH FLANGES WERE STARTING TO TEAR ON BOTH SIDES SO THE TRACH WAS CHANGED BEFORE IT WOULD TEAR ALL THE WAY THROUGH. IT WAS THEN NOTICED THAT THE BACKUP TRACHS ALSO HAD SMALL TEARS ON THEM. THE DEVICES ARE NOT AVAILABLE FOR INVESTIGATION SINCE THEY WERE DISCARDED. THERE WAS A PATIENT INVOLVEMENT BUT UNKNOWN HARM OR ADVERSE EVENT. THERE WAS 1 PATIENT AND 3 PRODUCT FAULTS. EMDR-19024, EMDR-19030 AND EMDR-19031 REPRESENT THE SAME PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19083974 ↗
• InjuryApr 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S TRACH FLANGES WERE STARTING TO TEAR ON BOTH SIDES SO THE TRACH WAS CHANGED BEFORE IT WOULD TEAR ALL THE WAY THROUGH. IT WAS THEN NOTICED THAT THE BACKUP TRACHS ALSO HAD SMALL TEARS ON THEM. THE DEVICES ARE NOT AVAILABLE FOR INVESTIGATION SINCE THEY WERE DISCARDED. THERE WAS A PATIENT INVOLVEMENT BUT UNKNOWN HARM OR ADVERSE EVENT. THERE WAS 1 PATIENT AND 3 PRODUCT FAULTS. EMDR-19024, EMDR-19030 AND EMDR-19031 REPRESENT THE SAME PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19083902 ↗
• InjuryJun 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION: THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM OR INJURY. PATIENT DID REPORT FEELING LIKE ?"SOMETHING WAS STUCK IN THEIR THROAT''.

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

  MAUDE report 17157994 ↗
• InjuryMay 25, 2023Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL. THE EXACT DATE IS NOT CLEAR, BUT IT WAS THE WEEKEND OF THE (B)(6) 2023 AND WAS WHILE IN SITU WITH THE PATIENT. THE PATIENT REPORTED "FEELING AS IF SOMETHING WAS STUCK IN HIS THROAT WHILE THE TRACHE TUBE WAS IN SITU".

  Patient problems: Discomfort; Insufficient Information

  MAUDE report 17004682 ↗
• InjuryNov 15, 2018Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT NINE DAYS FOLLOWING CANNULA CHANGE OUT TO A SMITHS MEDICAL PORTEX® BIVONA® UNCUFFED TRACHEOSTOMY TUBE A BREAKAGE TO THE FLANGE WAS NOTED. SUBSEQUENTLY, A TUBE CHANGE OUT WAS REQUIRED WITH NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8073731 ↗
• MalfunctionNov 8, 2018Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA UNCUFFED TRACHEOSTOMY TUBE COIL BROKE WHILE IN USE WITH A PATIENT. SUBSEQUENTLY, A TRACHEOSTOMY (TRACH) TUBE CHANGE OUT WAS REQUIRED AND THE BROKEN TRACH WAS REPLACED WITH A NON-SMITHS MEDICAL TRACH TUBE. THE PATIENT WAS ALSO ON A VENTILATOR AND WAS REPORTED TO BE IN STABLE CONDITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8053130 ↗
• MalfunctionMar 29, 2018Fracture; Fracture

  IT WAS REPORTED THAT A CUSTOMER REPLACED A PORTEX® BIVONA® UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE WITH A NEW ONE. TWO WEEKS LATER, A CRACK WAS FOUND IN THE FLANGE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7383522 ↗
• MalfunctionApr 26, 2017Cut In Material; Cut In Material

  IT WAS REPORTED THAT A PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE LEFT EYELET TORE THREE-QUARTERS OF THE WAY DURING USE ON A PATIENT. THE ISSUE WAS OBSERVED BY THE PATIENT'S PARENT WHEN SHE AWOKE FROM A NAP. THE TRACHEOSTOMY TUBE HAD BEEN IN USE FOR 2 WEEKS. IT WAS NOTED THAT DALE TRACHEOSTOMY TUBE TIES HAD BEEN USED TO HOLD THE TUBE IN PLACE. THE TUBE WAS DISCARDED AND REPLACED WITH A NEW TRACHEOSTOMY TUBE. NO PATIENT INJURY WAS REPORTED. THE ISSUE WAS CONSIDERED RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6522742 ↗

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-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-2604-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIR
• 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-2602-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOST
• Z-2596-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0M
• 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-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-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-2614-2024 · May 29, 2024 · Open, Classified
  a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Pr
• 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-2603-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/Lis
• 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-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-2594-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT T
• 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

…and 31 more.