Edi Catheter ENFit 12Fr/125 cm, 5pcs 6883903Recalls & reported problems
Maquet Critical Care AB · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07325710004661), received between Apr 19, 2023 and Jul 21, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
Patient problems
- Anxiety2
- Discomfort2
- Foreign Body In Patient2
- Pain2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2025Fracture; Fracture
InjuryJul 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT WAS RECEIVING NEURALLY CONTROLLED NAVA TREATMENT WHERE A NASO-GASTRIC EDI CATHETER IS USED FOR TRANSFER OF ELECTRICAL ACTIVITY OF THE DIAPHRAGM (EDI SIGNAL) TO THE VENTILATOR SYSTEM. THE PATIENT SUDDENLY HAD EPISODES OF VOMITING WHERE A PIECE OF THE EDI CATHETER WAS FOUND IN THE GASTRIC CONTENT. THE PATIENT EXPERIENCED DISCOMFORT, PAIN AND ANXIETY. THE EDI CATHETER WAS REMOVED, AND FOLLOW-UP CHEST X-RAY SHOWED A RESIDUAL CATHETER PIECE IN THE GASTRIC CAVITY. THERE IS NO INDICATION FOR ENDOSCOPIC REMOVAL. FINAL PATIENT OUTCOME WAS NO HARM. MANUFACTURER¿S REF # (B)(4).
Patient problems: Anxiety; Discomfort; Pain
MAUDE report 22539354 ↗InjuryApr 19, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE OF VENTILATION, WHEN THE EDI CATHETER WAS REMOVED FROM THE PATIENT, IT BROKE LEAVING THE TIP IN THE STOMACH. A GASTROSCOPY WAS NECESSARY TO REMOVE THE BROKEN TIP. THE FINAL PATIENT OUTCOME WAS NO HARM. MANUFACTURER'S REF #: (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 16768264 ↗InjuryApr 19, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE OF VENTILATION, WHEN THE EDI CATHETER WAS REMOVED FROM THE PATIENT, IT BROKE LEAVING THE TIP IN THE STOMACH. A GASTROSCOPY WAS NECESSARY TO REMOVE THE BROKEN TIP. THE FINAL PATIENT OUTCOME WAS NO HARM. MANUFACTURER'S REF #: (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 16767909 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page