Arndt G13279Recalls & reported problems
Cook Incorporated · Arndt Pediatric Endobronchial Blocker Set With Spherical Balloon · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002132795), received between Oct 15, 2019 and Apr 22, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Inflation Problem2
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A HAIR LIKE FIBER WAS FOUND INSIDE THE UNOPENED PACKAGING OF A ARNDT ENDOBRONCHIAL BLOCKER SET. IMAGES WERE PROVIDED CONFIRMING THE FOREIGN SUBSTANCE. NO PATIENT CONTACT HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19154100 ↗MalfunctionNov 4, 2019Inflation 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 Consequences Or Impact To Patient
MAUDE report 9273405 ↗MalfunctionOct 15, 2019Inflation Problem; Inflation Problem
ADDITIONAL INFORMATION RECEIVED ON 16OCT2019 STATED THAT THE UNEVEN BALLOON SHAPE WAS NOTICED BEFORE THE PRODUCT WAS USED. THEREFORE, THERE WAS NO PATIENT CONTACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9192404 ↗
Other TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR) devices
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- VivaSight™ 2 DLT Kit 37 Fr - LEFT 412371000Ambu A/S · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)1 recall10 reports
- HUDSON RCI IPN048995Teleflex Incorporated · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)58 reports
- VivaSight™ 2 DLT Kit 39 Fr - LEFT 412391000Ambu A/S · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)1 recall6 reports
- VivaSight™ 2 DLT Kit 41 Fr - LEFT 412411000Ambu A/S · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)1 recall2 reports
- VivaSight™ 2 DLT Kit 35 Fr - LEFT 412351000Ambu A/S · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)1 recall2 reports
- Portex 198-35LIcu Medical, Inc. · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)48 reports
- Portex 198-37LIcu Medical, Inc. · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)44 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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