ENVue® System ENV-20000Recalls & reported problems
Envizion Medical Ltd · For full information, Envue System User Manual (6100-1) and IFU (6201-01) OVERVIEW OF SYSTEM The ENvizion Medical ENvue System is an electromagnetic sensing device designed to aid qualified operators in the placement of the ENvizion Enteral Feeding Tube (EFT) into the stomach or small intestine of patients requiring enteral feeding. The ENvizion ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes, prior to commencing the delivery of enteral nutrition. Although this System has been designed to exacting specifications, it is not intended to replace trained personnel in the supervision of feeding tube placements. Only clinical personnel familiar with the placement of oro/nasoenteric tubes should perform tube placements. As placement is performed, the all-in-one PC displays the relative tip position and track. The entire placement is recorded and may be replayed later. The ENvizion Enteral Feeding Tube’s position must be confirmed per institution protocol (i.e., X- ray, pH measurement, etc.). 3. CONDITIONS FOR USE 3.1. INDICATIONS FOR USE The ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 8 Fr to 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes. The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B483EVN200000), received between Aug 3, 2023 and Mar 13, 2026 — classified as 1 death, 4 injuries.
The most frequently reported specific device problem is “Malposition of Device” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Malposition of Device2
- Activation, Positioning or Separation Problem1
Patient problems
- Low Oxygen Saturation2
- No Clinical Signs, Symptoms or Conditions2
- Pneumothorax1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
DeathMar 13, 2026Activation, Positioning or Separation Problem
PATIENT INFORMATION: 74-YEAR-OLD FEMALE. NOT MECHANICALLY VENTILATED. NO RECENT SURGICAL PROCEDURES. THE PATIENT EXPERIENCED TWO CARDIAC ARREST EVENTS (CODED TWICE). REASON FOR CURRENT HOSPITALIZATION: ACUTE ENCEPHALOPATHY. PAST MEDICAL HISTORY: MALIGNANCY (NOT SPECIFIED). REPORTED CAUSE OF DEATH: TENSION PNEUMOTHORAX ENVUE MACHINE WAS USED FOR NGT PLACEMENT AND THE USER REPORTED THAT THERE WAS NO DEVIATION MESSAGE ON SCREEN DURING PLACEMENT. AT THE TIME OF TUBE INSERTION, THERE WAS NO INDICATION OF RESPIRATORY DISTRESS. CHEST X RAY ON (B)(6) 2026, 22:06) WAS ORDERED POST PLACEMENT AND THERE WAS NO READ ON IT PRIOR TO MRT. PATIENT HAS HAD A STEADY DECLINE IN RESPIRATORY STATUS SINCE THEN. X RAY IMPRESSION STATED THAT NGT WAS IN RIGHT LOWER LOBE OF THE LUNG, WITH NO VISIBLE PNEUMOTHORAX, WITH BILATERAL EFFUSIONS AND ATELECTASIS. NGT WAS REMOVED AND SECOND CHEST X RAY ON (B)(6) 2026, 04:09) ORDERED POST REMOVAL TO CONFIRM NO PNEUMOTHORAX. SECOND X RAY SHOWED NO DISTINCT PNEUMOTHORAX, AS WELL AS RIGHT OVERLOAD AND PULMONARY EDEMA, BILATERAL EFFUSIONS (LEFT>RIGHT), PASSIVE ATELECTASIS (FAVORED OVER PNEUMOTHORAX). THE PATIENT'S CONDITION DETERIORATED ON (B)(6) 2026, 06:30) DESPITE INTUB
Patient problems: Pneumothorax
MAUDE report 24594481 ↗InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2023 ENVIZION WAS MADE AWARE THAT A LUNG PLACEMENT OCCURRED ON 11JUL2023 AND CAUSED THE PATIENT TO DESAT WITH SPO2 DIVING DOWN AS LOW AS 58%.
Patient problems: Low Oxygen Saturation
MAUDE report 17513394 ↗InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 13 JUL 2023 ENVIZION WAS MADE AWARE THAT A LUNG PLACEMENT OCCURRED ON (B)(6) 2023 AND CAUSED THE PATIENT TO DESAT WITH SPO2 DIVING DOWN AS LOW AS 58%.
Patient problems: Low Oxygen Saturation
MAUDE report 17511275 ↗InjuryAug 3, 2023Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem
A LUNG PLACEMENT OCCURRED ON (B)(6) 2023. INTERVENTION WAS REQUIRED TO REMOVE THE FEEDING TUBE FROM THE LUNG TO PREVENT INJURY. BASED ON THE INFORMATION PROVIDED NO ACTUAL INJURY OCCURRED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17450991 ↗InjuryAug 3, 2023Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem
A LUNG PLACEMENT OCCURRED ON (B)(6) 2023. INTERVENTION WAS REQUIRED TO REMOVE THE FEEDING TUBE FROM THE LUNG TO PREVENT INJURY. BASED ON THE INFORMATION PROVIDED NO ACTUAL INJURY OCCURRED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17450990 ↗
Other Tubes, Gastrointestinal (And Accessories) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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