MallinckrodtRecalls & reported problems across all models
Covidien LP · 73 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 523
- Deaths reported
- 1
- Injuries reported
- 145
- Recalls
- 0
We found 73 models of Mallinckrodt by Covidien LP in the FDA's device registry (GUDID). Together they are named in 523 adverse event reports in the FDA's MAUDE database, received between Mar 13, 2017 and Sep 17, 2026 — classified as 1 death, 145 injuries, 377 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (131 reports).
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
Most reported Mallinckrodt problems
Device problems
- Inflation Problem131
- Deflation Problem84
- Use of Device Problem81
- Gas/Air Leak45
- Leak/Splash23
- Defective Component21
- Air Leak19
- Contamination18
Patient problems
- No Patient Involvement227
- Extubate122
- No Information53
- No Clinical Signs, Symptoms or Conditions52
- No Consequences Or Impact To Patient44
- No Known Impact Or Consequence To Patient25
- Unintended Extubation24
- Low Oxygen Saturation4
Mallinckrodt models
73 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Mallinckrodt 18880Tube, tracheal (w/wo connector)60 reports
- Mallinckrodt 125037TUBE, BRONCHIAL (W/WO CONNECTOR)49 reports
- Mallinckrodt 126037TUBE, BRONCHIAL (W/WO CONNECTOR)47 reports
- Mallinckrodt 18875Tube, tracheal (w/wo connector)39 reports
- Mallinckrodt 18780Tube, tracheal (w/wo connector)39 reports
- Mallinckrodt 125035TUBE, BRONCHIAL (W/WO CONNECTOR)34 reports
- Mallinckrodt 18775Tube, tracheal (w/wo connector)32 reports
- Mallinckrodt 18870Tube, tracheal (w/wo connector)21 reports
- Mallinckrodt 125039TUBE, BRONCHIAL (W/WO CONNECTOR)16 reports
- Mallinckrodt 18770Tube, tracheal (w/wo connector)14 reports
- Mallinckrodt 86111Tube, tracheal (w/wo connector)12 reports
- Mallinckrodt 86113Tube, tracheal (w/wo connector)1 death9 reports
- Mallinckrodt 86451Tube, tracheal (w/wo connector)9 reports
- Mallinckrodt 110870Tube, tracheal (w/wo connector)8 reports
- Mallinckrodt 18750Tube, tracheal (w/wo connector)8 reports
- Mallinckrodt 18885Tube, tracheal (w/wo connector)7 reports
- Mallinckrodt 125032TUBE, BRONCHIAL (W/WO CONNECTOR)7 reports
- Mallinckrodt 86452Tube, tracheal (w/wo connector)7 reports
- Mallinckrodt 110875Tube, tracheal (w/wo connector)5 reports
- Mallinckrodt 86234Tube, tracheal (w/wo connector)5 reports
- Mallinckrodt 86551Tube, tracheal (w/wo connector)5 reports
- Mallinckrodt 86445Tube, tracheal (w/wo connector)5 reports
- Mallinckrodt 110880Tube, tracheal (w/wo connector)4 reports
- Mallinckrodt 126037TUBE, BRONCHIAL (W/WO CONNECTOR)4 reports
- Mallinckrodt 18790Tube, tracheal (w/wo connector)4 reports
- Mallinckrodt 125041TUBE, BRONCHIAL (W/WO CONNECTOR)3 reports
- Mallinckrodt 126035TUBE, BRONCHIAL (W/WO CONNECTOR)3 reports
- Mallinckrodt 86112Tube, tracheal (w/wo connector)3 reports
- Mallinckrodt 18760Tube, tracheal (w/wo connector)3 reports
- Mallinckrodt 18765Tube, tracheal (w/wo connector)3 reports
- Mallinckrodt 8888247064AIRWAY, NASOPHARYNGEAL2 reports
- Mallinckrodt 76255Tube, tracheal (w/wo connector)2 reports
- Mallinckrodt 96370Tube, tracheal (w/wo connector)2 reports
- Mallinckrodt 86550Tube, tracheal (w/wo connector)2 reports
- Mallinckrodt 86552Tube, tracheal (w/wo connector)2 reports
- Mallinckrodt 18865Tube, tracheal (w/wo connector)2 reports
- Mallinckrodt 18890Tube, tracheal (w/wo connector)2 reports
- Mallinckrodt 125239TUBE, BRONCHIAL (W/WO CONNECTOR)2 reports
- Mallinckrodt 86224Tube, tracheal (w/wo connector)2 reports
- Mallinckrodt 86225Tube, tracheal (w/wo connector)2 reports
- Mallinckrodt 86226Tube, tracheal (w/wo connector)2 reports
- Mallinckrodt 18755Tube, tracheal (w/wo connector)2 reports
- Mallinckrodt 86450Tube, tracheal (w/wo connector)2 reports
- Mallinckrodt 86462Tube, tracheal (w/wo connector)2 reports
- Mallinckrodt 85864STYLET, TRACHEAL TUBE2 reports
- Mallinckrodt 110890Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 96360Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 96375Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86263Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86265Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86553Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 5-18437AIRWAY, ESOPHAGEAL (OBTURATOR)1 report
- Mallinckrodt 5-18541AIRWAY, ESOPHAGEAL (OBTURATOR)1 report
- Mallinckrodt 86397Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86398Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 125137Attachment, breathing, positive end expiratory pressure1 report
- Mallinckrodt 125028TUBE, BRONCHIAL (W/WO CONNECTOR)1 report
- Mallinckrodt 126039TUBE, BRONCHIAL (W/WO CONNECTOR)1 report
- Mallinckrodt 86108Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86351Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86209Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86051Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86047Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86050Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86222Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86223Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86230Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 18785Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86453Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86443Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 86444Tube, tracheal (w/wo connector)1 report
- Mallinckrodt 85863STYLET, TRACHEAL TUBE1 report
- Mallinckrodt 85865STYLET, TRACHEAL TUBE1 report
Recent Mallinckrodt adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809485 ↗MalfunctionFeb 10, 2026Use of Device Problem
IT WAS REPORTED THAT THE CUFF OF THE BRONCO CATHETER DID NOT INFLATE PRIOR TO USE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24302956 ↗MalfunctionNov 12, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USE INSPECTION BRONCO CATHETER, THE CUFF COULD NOT BE INFLATED DUE TO AIR LEAKAGE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23532944 ↗MalfunctionNov 6, 2025Defective Component; Defective Component
IT WAS REPORTED THAT THE CUFF THE FIRST HAD A CRACK AND THE SECOND DEVICE HAD A HOLE PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23490245 ↗MalfunctionSep 18, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE CUFF OF THE BRONCHO CATHETER TUBE HAD AN AIR LEAK WHEN TESTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23080969 ↗InjurySep 10, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT AN ENDOTRACHEAL TUBE FAILED DURING PROCEDURE. TH CUFF THAT WOULD NOT STAY INFLATED. THE PATIENT WAS ABLE TO VOCALIZE AROUND THE ENDOTRACHEAL TUBE, AND LOW EXPIRATORY VOLUMES WERE OBSERVED. THE ENDOTRACHEAL TUBE WAS SWITCHED OVER A BOUGIE AND NEEDED TO BE REINTUBATED.
Patient problems: Hypoventilation; Tachycardia; Unintended Extubation
MAUDE report 23022156 ↗MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A DOUBLE-LUMEN ENDOBRONCHIAL TUBE WAS IMPLANTED BEFORE THE OPERATION, AND THE CUFF WAS FOUND TO BE LEAKING AIR. THE MEDICAL STAFF REPLACED THE TUBE A SECOND TIME WITH NO HARM CAUSED TO THE PATIENT.
Patient problems: Unintended Extubation
MAUDE report 23021936 ↗MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A DOUBLE-LUMEN ENDOBRONCHIAL TUBE WAS IMPLANTED BEFORE THE OPERATION, AND THE CUFF WAS FOUND TO BE LEAKING AIR. THE MEDICAL STAFF REPLACED THE TUBE A SECOND TIME WITH NO HARM CAUSED TO THE PATIENT.
Patient problems: Unintended Extubation
MAUDE report 23020510 ↗MalfunctionAug 26, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE ANESTHESIOLOGIST INJECTED AIR INTO THE CUFF DURING INTUBATION BUT FOUND NO PRESSURE IN THE CUFF, INDICATING A LEAK. THE TUBE WAS REPLACED, AND THE NEW TUBE FUNCTIONED PROPERLY, ALLOWING THE SURGERY TO PROCEED SMOOTHLY.
Patient problems: Unintended Extubation
MAUDE report 22898831 ↗MalfunctionAug 15, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THREE DOUBLE-LUMEN AND AN ENDOTRACHEAL TUBE'S CUFF EACH HAD AN INFLATION OR DEFLATION ISSUES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816098 ↗MalfunctionAug 12, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS NOT HOLDING AIR SHORTLY AFTER BEING PLACED. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 22790593 ↗MalfunctionAug 6, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THERE WAS CUFF AIR LEAKAGE DURING THE INFLATION AND DEFLATION TEST WITH THE TWO BRONCO CATHETER AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22730275 ↗MalfunctionJul 23, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE CUFF OF THE BRONCHO CATHETER TUBE HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22573824 ↗MalfunctionJul 1, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE CUFF OF THE TWO TRACHEOSTOMY TUBE HAD LEAK PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22375898 ↗InjuryJun 27, 2025Defective Component; Obstruction of Flow; Defective Component; Obstruction of Flow
IT WAS REPORTED THAT A CUFFED TRACHEOSTOMY TUBE WAS THEN INSERTED INTO THE TRACHEA, THE BALLOON WAS INFLATED, AND THE CIRCUIT WAS CONNECTED. THERE WAS POSITIVE END-TIDAL CO2. IT WAS NOTED SHORTLY THEREAFTER THAT THE PATIENT WAS NOT ACHIEVING ADEQUATE TIDAL VOLUMES ON THE VENT AND BEGAN DESATURATING TO LOW 80'S. THE PATIENT WAS BRANCHED PROMPTLY VIA THE TRACHEOSTOMY AND IT WAS NOTED THAT THE INFLATED CUFF WAS EXTENDING DISTAL TO THE END OF THE TUBE, PRODUCING SEVERE STENOSIS OF THE OPENING OF THE TRACHEOSTOMY TUBE. THE BALLOON WAS PARTIALLY DEFLATED AND THE OCCLUSION PROBLEM WAS RESOLVED AS SEEN ON BRONCHOSCOPY. AT THIS TIME, THE PATIENTS END TITLE, TIDAL VOLUMES, AND SATURATION ALL NORMALIZED.
Patient problems: Hypoventilation; Low Oxygen Saturation; Stenosis
MAUDE report 22350049 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
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