Mallinckrodt 125137Recalls & reported problems
Covidien LP · Endobronchial Tube Left with CPAP;Endobronchial Suction Catheter;Endobronchial Tube Accessories · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30884522008697), received between Sep 14, 2018 and Sep 14, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (1 report).
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.
Most reported problems
Device problems
- Component Missing1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2018Component Missing; Component Missing
ACCORDING TO THE REPORTER, THE DEVICE HAD MISSING COMPONENTS AND COULD NOT BE USED. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7876784 ↗
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- WaterPAP™ WP-7700Sunmed, LLC · Attachment, Breathing, Positive End Expiratory Pressure1 recall0 reports
- Pneupac 100/905/340-CHIcu Medical, Inc. · Attachment, breathing, positive end expiratory pressure18 reports
- Shiley 125139Covidien LP · Attachment, breathing, positive end expiratory pressure1 death6 reports
- Shiley 125137Covidien LP · Attachment, breathing, positive end expiratory pressure4 reports
- Pneupac 100/905/340Icu Medical, Inc. · Attachment, breathing, positive end expiratory pressure3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.