Edi Catheter ENFit 6Fr/49 cm, 5pcs 6883898Recalls & reported problems
Maquet Critical Care AB · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07325710004609), received between Apr 18, 2023 and Feb 3, 2026 — classified as 12 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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
- Insufficient Device Problem Information8
- Adverse Event Without Identified Device or Use Problem4
- Mechanical Problem1
- Stretched1
Patient problems
- Bowel Perforation6
- Pneumothorax4
- Bradycardia2
- Low Oxygen Saturation2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2026Insufficient Device Problem Information
MANUFACTURER'S REF #: (B)(4).
Patient problems: Bradycardia; Low Oxygen Saturation
MAUDE report 24252544 ↗InjuryFeb 3, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT DURING VENTILATOR TREATMENT IN NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE, AN ALARM FOR EDI CATHETER FAILURE WAS GENERATED. THE PATIENT DESATURATED TO 50% AND BECAME BRADYCARDIC. THE EDI CATHETER WAS REPLACED, AND THE PATIENT STABILIZED. FINAL PATIENT OUTCOME WAS NO HARM. MANUFACTURER¿S REF #: (B)(4).
Patient problems: Bradycardia; Low Oxygen Saturation
MAUDE report 24243471 ↗InjurySep 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING VENTILATION IN NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE, A GASTRIC PERFORATION WITH THE EDI CATHETER OCCURRED. THERE WAS NO PATIENT HARM. MANUFACTURER¿S REF #: (B)(4).
Patient problems: Bowel Perforation
MAUDE report 23037339 ↗InjurySep 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjurySep 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjurySep 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjurySep 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjurySep 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING VENTILATION IN NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE, A GASTRIC PERFORATION WITH THE EDI CATHETER OCCURRED. THERE WAS NO PATIENT HARM. MANUFACTURER¿S REF #: (B)(4).
Patient problems: Bowel Perforation
MAUDE report 22975702 ↗MalfunctionApr 17, 2025Mechanical Problem; Mechanical Problem
MANUFACTURER'S REF #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21855253 ↗MalfunctionNov 15, 2023Stretched; Stretched
IT WAS REPORTED THAT AFTER REMOVAL OF THE EDI CATHETER, THE USER MEASURED THE LENGTH AND FOUND THAT THE TOTAL LENGTH WAS 52 CM INSTEAD OF SPECIFIED 49 CM. THERE WAS NO PATIENT HARM. MANUFACTURER¿S REF #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18137897 ↗InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING PATIENT TREATMENT IN INVASIVE NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE OF VENTILATION, THE PATIENT DEVELOPED A PNEUMOTHORAX. THE PATIENT REMAINED ON THE VENTILATOR AND WAS SUBSEQUENTLY EXTUBATED WITH CONTINUED TREATMENT IN NON INVASIVE VENTILATION (NIV) MODE OF VENTILATION. FINAL PATIENT OUTCOME WAS NO INJURY. MANUFACTURER'S REF #: (B)(4).
Patient problems: Pneumothorax
MAUDE report 16768532 ↗InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING PATIENT TREATMENT IN INVASIVE NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE OF VENTILATION, THE PATIENT DEVELOPED A PNEUMOTHORAX. THE PATIENT REMAINED ON THE VENTILATOR AND WAS SUBSEQUENTLY EXTUBATED WITH CONTINUED TREATMENT IN NON INVASIVE VENTILATION (NIV) MODE OF VENTILATION. FINAL PATIENT OUTCOME WAS NO INJURY. MANUFACTURER'S REF #: (B)(4).
Patient problems: Pneumothorax
MAUDE report 16768263 ↗InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING PATIENT TREATMENT IN INVASIVE NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE OF VENTILATION, THE PATIENT DEVELOPED A PNEUMOTHORAX. THE PATIENT REMAINED ON THE VENTILATOR AND WAS SUBSEQUENTLY EXTUBATED WITH CONTINUED TREATMENT IN NON INVASIVE VENTILATION (NIV) MODE OF VENTILATION. FINAL PATIENT OUTCOME WAS NO INJURY. MANUFACTURER'S REF #: (B)(4).
Patient problems: Pneumothorax
MAUDE report 16760996 ↗InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING PATIENT TREATMENT IN INVASIVE NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE OF VENTILATION, THE PATIENT DEVELOPED A PNEUMOTHORAX. THE PATIENT REMAINED ON THE VENTILATOR AND WAS SUBSEQUENTLY EXTUBATED WITH CONTINUED TREATMENT IN NON INVASIVE VENTILATION (NIV) MODE OF VENTILATION. FINAL PATIENT OUTCOME WAS NO INJURY. MANUFACTURER'S REF #: (B)(4).
Patient problems: Pneumothorax
MAUDE report 16760995 ↗
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
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- 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
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- Salem Sump 7771610ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors1 death18 reports
- EndoVive Safety PEG Kit M00509030Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors13 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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