Edi Catheter ENFit 8Fr/50 cm, 5pcs 6883900Recalls & reported problems
Maquet Critical Care AB · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07325710004630), received between Sep 13, 2024 and Sep 13, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Pressure Problem” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K153688); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Pressure Problem2
Patient problems
- Hyperventilation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 13, 2024Pressure Problem; Pressure Problem
IT WAS REPORTED THAT DURING NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) VENTILATION, THE PATIENT BECAME TACHYPNEIC. THE EDI CATHETER POSITION WAS CHANGED. AFTER ADVANCEMENT, THE EDI PEAKS INCREASED DRAMATICALLY BUT THE PATIENT CONTINUED TO REMAIN TACHYPNEIC. THE DECISION WAS MADE TO EXTUBATE THE PATIENT TO ROOM AIR AS THE CO2 LEVEL WAS LOW. THE EDI CATHETER WAS REPOSITIONED FOLLOWING EXTUBATION AND PROPER POSITIONING WAS ESTABLISHED. THE EDI PEAKS RETURNED TO LOWER VALUES. THE EDI CATHETER WAS FINALLY REMOVED AND THE PATIENT REMAINS ON HIGH FLOW NASAL CANNULA IN ROOM AIR. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).
Patient problems: Hyperventilation
MAUDE report 20212639 ↗InjurySep 13, 2024Pressure Problem; Pressure Problem
IT WAS REPORTED THAT DURING NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) VENTILATION, THE PATIENT BECAME TACHYPNEIC. THE EDI CATHETER POSITION WAS CHANGED. AFTER ADVANCEMENT, THE EDI PEAKS INCREASED DRAMATICALLY BUT THE PATIENT CONTINUED TO REMAIN TACHYPNEIC. THE DECISION WAS MADE TO EXTUBATE THE PATIENT TO ROOM AIR AS THE CO2 LEVEL WAS LOW. THE EDI CATHETER WAS REPOSITIONED FOLLOWING EXTUBATION AND PROPER POSITIONING WAS ESTABLISHED. THE EDI PEAKS RETURNED TO LOWER VALUES. THE EDI CATHETER WAS FINALLY REMOVED AND THE PATIENT REMAINS ON HIGH FLOW NASAL CANNULA IN ROOM AIR. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).
Patient problems: Hyperventilation
MAUDE report 20210623 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K153688. One submission often covers many models, so check the product and lot details in each record.
- Z-1221-2019 · Mar 20, 2019 · TerminatedMaquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tub
Other Gastrointestinal Tubes With Enteral Specific Connectors devices
- EndoVive Safety PEG Kit M00509000Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall32 reports
- EndoVive Safety PEG Kit M00509010Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall16 reports
- EndoVive Standard PEG Kit M00509050Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall6 reports
- Salem Sump 8888264986ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall1 death2 reports
- Salem Sump 8888268060ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall0 reports
- Salem Sump 7771810ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors28 reports
- Salem Sump 7771610ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors1 death18 reports
- Edi Catheter ENFit 6Fr/49 cm, 5pcs 6883898Maquet Critical Care AB · Gastrointestinal Tubes With Enteral Specific Connectors14 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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