NA 1898001 (UDI 00643169305069)Recalls & reported problems
Medtronic Xomed, Inc. · CONSOLE 1898001 IPC ROHS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169305069), received between Feb 7, 2019 and Feb 7, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Remains Activated” (1 report).
1 other recall cover devices cleared under the same FDA submission (K081277); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Device Remains Activated1
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.
InjuryFeb 7, 2019Device Remains Activated; Device Remains Activated
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PUMP FOR THE ENDOSCRUB WAS RUNNING ON FULL CONSTANTLY DURING A PROCEDURE. THE STAFF CHECKED THAT THE PUMP 1 WAS PLUGGED IN PROPERLY HOWEVER, NO RESULT WAS SEEN SO THE PUMP WAS TURNED OFF. THE SURGEON HAD COMPLETED MOST OF THE FUNCTIONAL ENDOSCOPIC SURGERY PROCEDURE HOWEVER, DUE TO POOR VISUALIZATION DECIDED TO ABANDON THE CASE. THE PATIENT WAS ANESTHETIZED AND THE PROCEDURE WAS ALMOST FINISHED. THERE WAS DELAY WITH THE PROCEDURE. THE PROCEDURE WAS ABANDONED. THERE WAS NO PATIENT IMPACT OR INJURY. THE PATIENT'S CURRENT STATUS IS SATISFACTORY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8317297 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K081277. One submission often covers many models, so check the product and lot details in each record.
- Z-0961-2022 · Dec 15, 2021 · TerminatedSoftware 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND E
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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
- 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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