Melker G32193Recalls & reported problems
Cook Incorporated · Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set · Class 2
All models of Melker (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002321939), received between Jul 30, 2020 and Aug 18, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Inflation Problem” (2 reports).
1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Mar 5, 2026Open, Classified
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1785-2026 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗
Most reported problems
Device problems
- Inflation Problem2
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Swelling1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2020Inflation Problem; Inflation Problem
ADDITIONAL INFORMATION WAS RECEIVED ON 19AUG2020. NO UNINTENDED SECTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY. THE PATIENT WAS HOSPITALIZED BUT IT IS UNKNOWN IF THEIR HOSPITALIZATION WAS PROLONGED. THIS OCCURRENCE CAUSED ADDITIONAL SWELLING TO THE PATIENT AND REQUIRED INTUBATION. THE COMPONENT WAS PLACED IN THE TRACHEA. THERE WAS DIFFICULTY EXPERIENCED INSERTING THIS DEVICE AS THE BALLOON WAS FAULTY. THE TUBE WAS IMMEDIATELY REMOVED WHEN PLACED AND THE PATIENT REQUIRED EMERGENT INTUBATION. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. IT IS UNKNOWN IF AN INITIAL INFLATION CHECK WAS PERFORMED PRIOR TO DEVICE PLACEMENT.
Patient problems: No Code Available; Swelling
MAUDE report 10421492 ↗MalfunctionJul 30, 2020Inflation Problem
BALLOON IN CRICOTHYROTOMY KIT WOULD NOT INFLATE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10343585 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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