BivonaRecalls & reported problems across all models
Icu Medical, Inc. · 469 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
29 open recalls name at least one Bivona model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,811
- Deaths reported
- 21
- Injuries reported
- 784
- Recalls
- 29
We found 469 models of Bivona by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 2,811 adverse event reports in the FDA's MAUDE database, received between Jan 16, 2017 and Sep 30, 2026 — classified as 21 deaths, 784 injuries, 2,006 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (877 reports).
29 FDA recall records name at least one of these models by its device identifier, 29 still open.
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
Bivona recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 11 of these models · Recall details · FDA record ↗
- 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-2614-2024 · Root cause: Under Investigation by firm · names 7 of these models · Recall details · FDA record ↗
- 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-2613-2024 · Root cause: Under Investigation by firm · names 7 of these models · Recall details · FDA record ↗
- 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 · names 5 of these models · Recall details · FDA record ↗
- 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-2611-2024 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗
- 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-2610-2024 · Root cause: Under Investigation by firm · names 7 of these models · Recall details · FDA record ↗
- 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-2609-2024 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗
- 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-2608-2024 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗
- 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-2607-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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-2606-2024 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- 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-2605-2024 · Root cause: Under Investigation by firm · names 11 of these models · Recall details · FDA record ↗
- 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-2604-2024 · Root cause: Under Investigation by firm · names 7 of these models · Recall details · FDA record ↗
- 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-2603-2024 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗
- 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 · names 11 of these models · Recall details · FDA record ↗
- 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-2601-2024 · Root cause: Under Investigation by firm · names 6 of these models · Recall details · FDA record ↗
- 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-2600-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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-2599-2024 · Root cause: Under Investigation by firm · names 7 of these models · Recall details · FDA record ↗
- 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-2598-2024 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗
- 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-2597-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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-2596-2024 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗
- 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 · names 7 of these models · Recall details · FDA record ↗
- 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-2594-2024 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- 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-2593-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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-2592-2024 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗
- 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-2591-2024 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- 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-2590-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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-2589-2024 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- 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-2588-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Aug 22, 2023Open, Classified
The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).
Z-0205-2024 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported Bivona problems
Device problems
- Inflation Problem877
- Leak/Splash311
- Break231
- Gas/Air Leak204
- Material Split, Cut or Torn125
- Fluid/Blood Leak105
- Material Puncture/Hole86
- Defective Device81
Patient problems
- No Clinical Signs, Symptoms or Conditions1,514
- No Consequences Or Impact To Patient483
- Insufficient Information254
- No Known Impact Or Consequence To Patient183
- No Information84
- Decreased Respiratory Rate60
- Low Oxygen Saturation52
- Airway Obstruction35
Bivona models
469 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Bivona 67PFSS35Tube tracheostomy and tube cuff1 recall166 reports
- Bivona 670180Tube tracheostomy and tube cuff1 recall140 reports
- Bivona 670170Tube tracheostomy and tube cuff1 recall10 deaths132 reports
- Bivona 67PFSS40Tube tracheostomy and tube cuff1 recall115 reports
- Bivona 67P055Tube tracheostomy and tube cuff1 recall84 reports
- Bivona 60P045Tube tracheostomy and tube cuff2 recalls12 reports
- Bivona 67PFSS45Tube tracheostomy and tube cuff1 recall61 reports
- Bivona 67NFPS35Tube tracheostomy and tube cuff1 recall60 reports
- Bivona 60PFSS40Tube tracheostomy and tube cuff1 recall57 reports
- Bivona 67SP045Tube tracheostomy and tube cuff1 recall47 reports
- Bivona 67P050Tube tracheostomy and tube cuff1 recall41 reports
- Bivona 60PFSS35Tube tracheostomy and tube cuff1 recall37 reports
- Bivona 60PFSS45Tube tracheostomy and tube cuff1 recall37 reports
- Bivona 67PFS50Tube tracheostomy and tube cuff1 recall35 reports
- Bivona 67P040Tube tracheostomy and tube cuff1 recall35 reports
- Bivona 67PFPS60Tube tracheostomy and tube cuff1 recall34 reports
- Bivona 67PFSS50Tube tracheostomy and tube cuff1 recall34 reports
- Bivona 67PFS40Tube tracheostomy and tube cuff1 recall31 reports
- Bivona 67N035Tube tracheostomy and tube cuff1 recall31 reports
- Bivona 750180Tube tracheostomy and tube cuff1 recall2 deaths30 reports
- Bivona 67P035Tube tracheostomy and tube cuff1 recall27 reports
- Bivona 67SP040Tube tracheostomy and tube cuff1 recall26 reports
- Bivona 60NFP40Tube tracheostomy and tube cuff1 recall25 reports
- Bivona 67PFS45Tube tracheostomy and tube cuff1 recall23 reports
- Bivona 67NFPS30Tube tracheostomy and tube cuff1 recall23 reports
- Bivona 67SP035Tube tracheostomy and tube cuff1 recall21 reports
- Bivona 67SN035Tube tracheostomy and tube cuff1 recall20 reports
- Bivona 60SP040Tube, tracheostomy (w/wo connector)1 recall20 reports
- Bivona 67PFS35Tube tracheostomy and tube cuff1 recall19 reports
- Bivona 60SP035Tube tracheostomy and tube cuff1 recall3 deaths19 reports
- Bivona 67SP050Tube tracheostomy and tube cuff1 recall19 reports
- Bivona 670160Tube tracheostomy and tube cuff69 reports
- Bivona 750170Tube tracheostomy and tube cuff1 recall19 reports
- Bivona 67SP055Tube tracheostomy and tube cuff1 recall16 reports
- Bivona 60P055Tube tracheostomy and tube cuff1 recall16 reports
- Bivona 67P030Tube tracheostomy and tube cuff1 recall16 reports
- Bivona 67P045Tube tracheostomy and tube cuff1 recall4 deaths16 reports
- Bivona 67PFPS45Tube tracheostomy and tube cuff1 recall15 reports
- Bivona 67PFSS55Tube tracheostomy and tube cuff1 recall15 reports
- Bivona 67SP030Tube tracheostomy and tube cuff1 recall15 reports
- Bivona 60PFS40Tube tracheostomy and tube cuff1 recall15 reports
- Bivona 67PFSS30Tube tracheostomy and tube cuff1 recall14 reports
- Bivona 60PFS45Tube tracheostomy and tube cuff1 recall14 reports
- Bivona 60NFPS35Tube tracheostomy and tube cuff1 recall14 reports
- Bivona 60SP050Tube, tracheostomy (w/wo connector)1 recall13 reports
- Bivona 67N030Tube tracheostomy and tube cuff1 recall13 reports
- Bivona 60P040Tube, tracheostomy (w/wo connector)1 recall12 reports
- Bivona 750160Tube tracheostomy and tube cuff1 recall12 reports
- Bivona 67PFPS40Tube tracheostomy and tube cuff1 recall11 reports
- Bivona 67PFPS50Tube tracheostomy and tube cuff1 recall11 reports
- Bivona 60PFS50Tube tracheostomy and tube cuff1 recall11 reports
- Bivona 67PFS55Tube tracheostomy and tube cuff1 recall10 reports
- Bivona 67NFPS40Tube tracheostomy and tube cuff1 recall10 reports
- Bivona 67PFS30Tube tracheostomy and tube cuff1 recall9 reports
- Bivona 67SN025Tube tracheostomy and tube cuff1 recall9 reports
- Bivona 67SN030Tube tracheostomy and tube cuff1 recall9 reports
- Bivona 67PFP60Tube tracheostomy and tube cuff1 recall8 reports
- Bivona 60SP045Tube, tracheostomy (w/wo connector)1 recall8 reports
- Bivona 60P050Tube tracheostomy and tube cuff1 recall7 reports
- Bivona 60PFSS30Tube tracheostomy and tube cuff1 recall7 reports
- Bivona 60PFPS40Tube tracheostomy and tube cuff1 recall7 reports
- Bivona 67PFPS55Tube tracheostomy and tube cuff1 recall6 reports
- Bivona 67NFP40Tube tracheostomy and tube cuff1 recall5 reports
- Bivona 60SN040Tube, tracheostomy (w/wo connector)1 recall5 reports
- Bivona 65SP035Tube tracheostomy and tube cuff1 recall5 reports
- Bivona 60SP055Tube tracheostomy and tube cuff1 recall5 reports
- Bivona 60PFS55Tube tracheostomy and tube cuff1 recall5 reports
- Bivona 60SN035Tube, tracheostomy (w/wo connector)1 recall4 reports
- Bivona 67SN040Tube tracheostomy and tube cuff1 recall4 reports
- Bivona 65SP040Tube tracheostomy and tube cuff1 recall4 reports
- Bivona 65SP045Tube tracheostomy and tube cuff1 recall4 reports
- Bivona 60SP030Tube tracheostomy and tube cuff1 recall4 reports
- Bivona 60PFP40Tube tracheostomy and tube cuff1 recall4 reports
- Bivona 60PFS35Tube tracheostomy and tube cuff1 recall4 reports
- Bivona 67PFP50Tube tracheostomy and tube cuff1 recall3 reports
- Bivona 67PFP55Tube tracheostomy and tube cuff1 recall3 reports
- Bivona 67PFSS25Tube tracheostomy and tube cuff1 recall3 reports
- Bivona 67NFP35Tube tracheostomy and tube cuff1 recall3 reports
- Bivona 67NFPS25Tube tracheostomy and tube cuff1 recall3 reports
- Bivona 65SN035Tube tracheostomy and tube cuff1 recall3 reports
- Bivona 67SP025Tube tracheostomy and tube cuff1 recall3 reports
- Bivona 65P050Tube tracheostomy and tube cuff1 recall3 reports
- Bivona 60NFP30Tube tracheostomy and tube cuff1 recall3 reports
- Bivona 60PFPS50Tube tracheostomy and tube cuff1 recall3 reports
- Bivona 60PFSS55Tube tracheostomy and tube cuff1 recall3 reports
- Bivona 60PFP60Tube tracheostomy and tube cuff1 recall3 reports
- Bivona 67PFP45Tube tracheostomy and tube cuff1 recall2 reports
- Bivona 65SP025Tube tracheostomy and tube cuff1 recall2 reports
- Bivona 60N025Tube, tracheostomy (w/wo connector)1 recall2 reports
- Bivona 60P035Tube, tracheostomy (w/wo connector)1 recall2 reports
- Bivona 60PFP45Tube tracheostomy and tube cuff1 recall2 reports
- Bivona 65P030Tube tracheostomy and tube cuff1 recall2 reports
- Bivona 65P040Tube tracheostomy and tube cuff1 recall2 reports
- Bivona 65P045Tube tracheostomy and tube cuff1 recall2 reports
- Bivona 65P055Tube tracheostomy and tube cuff1 recall2 reports
- Bivona 67N040Tube tracheostomy and tube cuff1 recall2 reports
- Bivona 60NFP35Tube tracheostomy and tube cuff1 recall2 reports
- Bivona 60PFSS50Tube tracheostomy and tube cuff1 recall2 reports
- Bivona 67NFP25Tube tracheostomy and tube cuff1 recall1 report
- Bivona 67NFP30Tube tracheostomy and tube cuff1 recall1 report
Recent Bivona adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951802 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940150 ↗MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939873 ↗MalfunctionSep 28, 2026Inflation Problem
It was reported that the tracheostomy tube experienced unintended inflation of the inner cuff when air was introduced into the outer cuff, which prevented the patient from speaking. The issue was identified after the device had been placed in the patient's airway. There was patient involvement associated with this event; however, no patient harm or adverse effects were reported, as the patient remained under continuous monitoring.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916124 ↗MalfunctionSep 25, 2026Gas/Air Leak
It was stated that the tracheostomy tube was placed and found leakage. There was a patient involvement and there was unknown patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897193 ↗MalfunctionSep 25, 2026Gas/Air Leak
It was stated that the tracheostomy tube was placed and found leakage. There was a patient involvement and there was unknown patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897171 ↗MalfunctionSep 24, 2026Break
It was reported that the Bivona Tracheostomy Tube was in the patient and it broke in half. There was patient involvement with no harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886584 ↗MalfunctionSep 22, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860457 ↗MalfunctionSep 21, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848350 ↗MalfunctionSep 21, 2026Leak/Splash
A cuff leakage was identified on the 21st day of use while the device was in use on a patient at the hospital. The issue was resolved by replacing the device with another unit. Although the patient was involved at the time of the event, no patient harm or adverse effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838933 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829305 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829215 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829095 ↗MalfunctionSep 18, 2026Inflation Problem; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823433 ↗InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50596628 ↗
Other Icu Medical, Inc. products
- CADD123 models · 53,012 reports · 21 recalls
- Medfusion16 models · 13,114 reports · 5 recalls
- Level 152 models · 3,733 reports · 1 recall
- Portex409 models · 3,479 reports · 5 recalls
- Cleo6 models · 2,782 reports
- Pneupac23 models · 1,972 reports
- Medex98 models · 774 reports · 23 recalls
- Plum26 models · 1,358 reports · 6 recalls
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.
How reports and recalls are matched · Editorial policy · Report an error on this page