Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection SBRD-16-ENFRecalls & reported problems
Xeridiem Medical Devices, Inc. · Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 16 FR · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002447820), received between Feb 15, 2018 and Jan 30, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Unintended Deflation” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Unintended Deflation1
Patient problems
- Gastrointestinal Hemorrhage1
- Post Operative Wound Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2025Unintended Deflation; Unintended Deflation
AS PER ESOKS TRANSLATION: (B)(4) EMAIL FROM CUSTOMER. EMAIL FROM CUSTOMER TO (B)(4). FOLLOWING A GASTROSTOMY ON (B)(6)2024, THE MEDICAL STAFF OBSERVED BLEEDING AT THE ORIFICE ON THE (B)(6)2025. LOCAL CARE IS THEN PROVIDED. 03/12/2025 IN THE MORNING: DISCOVERY OF A BALLOON DEFLATED: THE PROBE IS REMOVED ALLOWING THE OBSERVATION OF A POROUS BALLOON. DEVICE IS AVAILABLE FOR RETURN. DATE OF INCIDENT: (B)(6)2025. LOCATION OF INCIDENT: RESUSCITATION. CIRCUMSTANCES OF INCIDENT / DESCRIPTION OF FACTS. FOLLOWING A GASTRONOMY ON (B)(6)2024, WE NOTICED BLEEDING AROUND THE OPENING ON 02/01: THE AREA WAS THEN TREATED. ON THE MORNING OF (B)(6)2025: BALLOON FOUND TO BE DEFLATED: THE TUBE WAS REMOVED ENABLING US TO SEE THAT THE BALLOON WAS POROUS. CLINICAL CONSEQUENCES OBSERVED. NO DIRECT CLINICAL CONSEQUENCES. PRECAUTIONARY MEASURES AND ACTIONS TAKEN: THE LABORATORY HAS BEEN INFORMED AND THE DEVICE IS BEING HELD AT THE PHARMACY IN CASE THE LABORATORY WISHES TO ANALYSE IT. THE CUSTOMER CONFIRMED THE INCIDENT DID TAKE PLACE ON (B)(6)2025.
Patient problems: Gastrointestinal Hemorrhage
MAUDE report 21277716 ↗InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT PRESENTED WITH WOUNDS WITH PUS AND NECROSIS OF THE SKIN UNDER THE ANCHORS. PATIENT OUTCOME: DISINFECTION AND WOUND CARE.
Patient problems: Post Operative Wound Infection
MAUDE report 7273847 ↗
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-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 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