ArndtRecalls & reported problems across all models
Cook Incorporated · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 8 models of Arndt by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Nov 10, 2016 and May 15, 2026 — classified as 3 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (19 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 Arndt problems
Device problems
- Inflation Problem19
- Deflation Problem8
- Material Rupture6
- Gas/Air Leak5
- Device Contaminated During Manufacture or Shipping2
- Air Leak1
- Break1
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Patient Involvement5
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient4
- Insufficient Information3
- Device Embedded In Tissue or Plaque1
- Hemorrhage/Blood Loss/Bleeding1
- No Code Available1
Arndt models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Arndt G44109TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)9 reports
- Arndt G44114TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)9 reports
- Arndt G44111TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)7 reports
- Arndt G13279TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)3 reports
- Arndt G26907TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)3 reports
- Arndt G44120TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)3 reports
- Arndt G13280TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)2 reports
- Arndt G13282TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)1 report
Recent Arndt adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Inflation Problem
IT WAS REPORTED THAT AN ARNDT ENDOBRONCHIAL BLOCKER DID NOT INFLATE PRIOR TO USE IN AN UNKNOWN PROCEDURE FOR AN UNKNOWN PATIENT. AT THIS TIME, NO HARM HAS BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAVE BEEN REQUESTED BUT ARE CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25183382 ↗MalfunctionFeb 17, 2026Material Rupture
ADDITIONAL INFORMATION WAS PROVIDED ON 25FEB2026. THE PATIENT DID NOT HAVE TORTUOUS ANATOMY. IT IS UNKNOWN IF THE DEVICE WAS TEST INFLATED BEFORE INSERTION BECAUSE IT WAS AN EMERGENCY AND NO ONE IS ABLE TO REMEMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367763 ↗MalfunctionJan 14, 2026Material Rupture; Detachment of Device or Device Component
IN ADDITIONAL INFORMATION PROVIDED 16JAN2026, THE PHYSICIANS STATED THE ISSUE IS RELATED TO A USAGE ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24069397 ↗MalfunctionJan 2, 2026Deflation Problem; Inflation Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23945898 ↗MalfunctionDec 10, 2025Inflation Problem; Inflation Problem
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23768193 ↗MalfunctionDec 1, 2025Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak
IN ADDITIONAL INFORMATION RECEIVED ON 09DEC2025, IT WAS REPORTED THAT A 1.5ML VOLUME WAS USED TO INFLATE THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23687548 ↗MalfunctionNov 17, 2025Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak
COOK WAS NOTIFIED THAT DURING PREOPERATIVE PREPARATION; THE BALLOON WAS TEST INFLATED AND WAS FOUND TO INFLATE SYMMETRICALLY AND LEAK. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THE DEVICE WAS RETURNED ON (B)(6) 2025 AND A PINHOLE WAS FOUND IN THE SEAM OF THE BALLOON. THE BALLOON WAS INFLATED WITH 2 CC OF AIR, BUT WOULD NOT STAY INFLATED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23576088 ↗MalfunctionOct 27, 2025Inflation Problem; Inflation Problem
THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H11.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393084 ↗MalfunctionJul 22, 2025Inflation Problem; Material Rupture; Inflation Problem; Material Rupture
THE DEVICE WAS RETURNED FOR INVESTIGATION ON 13NOV2025. DURING PRELIMINARY DEVICE EVALUATION, IT WAS DETERMINED THE BALLOON OF THE ARNDT ENDOBRONCHIAL BLOCKER CATHETER WAS TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22566493 ↗MalfunctionJun 24, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT THE BALLOON FROM AN ARNDT ENDOBRONCHIAL BLOCKER SET LEAKED. THE DEVICE WAS REQUIRED FOR A CRYOPULMONARY BIOPSY. THE BALLOON WAS TEST INFLATED WITH 4 ML WHEN THE LEAK WAS DISCOVERED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER, NEW DEVICE AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22322595 ↗MalfunctionJun 10, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT THE BLOCKER BALLOON FROM AN ARNDT ENDOBRONCHIAL BLOCKER SET WOULD NOT RETAIN AIR. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22179660 ↗MalfunctionApr 22, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT THE BALLOON INCLUDED IN THE ARNDT ENDOBRONCHIAL BLOCKER SET WAS UNABLE TO BE INFLATED DURING A LUNG ISOLATION FOR A LUNG BIOPSY PROCEDURE. PER THE CUSTOMER, THERE SEEMED TO BE A HOLE IN THE BALLOON. IT WAS NOTED THAT MINIMAL PRESSURE WAS APPLIED DURING BALLOON INFLATION USING THE PROVIDED SYRINGE PRIOR TO PATIENT USE. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT, AND AN UNSPECIFIED DOUBLE-LUMEN TUBE WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21884610 ↗MalfunctionMar 26, 2025Inflation Problem; Material Rupture; Inflation Problem; Material Rupture
IT WAS REPORTED THAT THE BALLOON INCLUDED IN THE ARNDT ENDOBRONCHIAL BLOCKER SET FAILED TO INFLATE AND LEAKED DURING AN AIRWAY CRYOBIOPSY PROCEDURE IN A PATIENT OF UNKNOWN AGE AND GENDER. THE BALLOON WAS INFLATED WITH 5ML OF AIR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21701082 ↗MalfunctionMar 25, 2025Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak
IT WAS REPORTED THAT THE BALLOON FROM AN ARNDT ENDOBRONCHIAL BLOCKER SET LEAKED DURING TESTING, PRIOR TO PATIENT CONTACT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21691679 ↗MalfunctionMar 25, 2025Material Rupture; Gas/Air Leak; Material Rupture; Gas/Air Leak
IT WAS REPORTED THAT THE BALLOON FROM AN ARNDT ENDOBRONCHIAL BLOCKER SET LEAKED DURING TESTING, PRIOR TO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21691611 ↗
Other Cook Incorporated products
All Cook Incorporated devices →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.
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