Mini ONE Balloon ButtonRecalls & reported problems across all models

We found 15 models of Mini ONE Balloon Button by Applied Medical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Feb 22, 2017 and Oct 15, 2025 — classified as 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Mini ONE Balloon Button problems

Mini ONE Balloon Button models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Mini ONE® Balloon Button M1-5-1208

  Tubes, Gastrointestinal (And Accessories)
  5 reports
• Mini ONE® Balloon Button M1-5-1208-I

  Tubes, Gastrointestinal (And Accessories)
  4 reports
• Mini ONE® Balloon Button M1-5-1410-I

  Tubes, Gastrointestinal (And Accessories)
  4 reports
• Mini ONE® Balloon Button M1-5-1215

  Tubes, Gastrointestinal (And Accessories)
  3 reports
• Mini ONE® Balloon Button M1-5-1210

  Tubes, Gastrointestinal (And Accessories)
  2 reports
• Mini ONE® Balloon Button M1-5-1412

  Tubes, Gastrointestinal (And Accessories)
  2 reports
• Mini ONE® Balloon Button M1-5-1417

  Tubes, Gastrointestinal (And Accessories)
  2 reports
• Mini ONE® Balloon Button M1-5-1210-I

  Tubes, Gastrointestinal (And Accessories)
  2 reports
• Mini ONE® Balloon Button M1-5-1417-I

  Tubes, Gastrointestinal (And Accessories)
  2 reports
• Mini ONE® Balloon Button SM1-5-1255

  Tubes, Gastrointestinal (And Accessories)
  2 reports
• Mini ONE® Balloon Button M1-5-1212

  Tubes, Gastrointestinal (And Accessories)
  1 report
• Mini ONE® Balloon Button M1-5-1410

  Tubes, Gastrointestinal (And Accessories)
  1 report
• Mini ONE® Balloon Button M1-5-1415

  Tubes, Gastrointestinal (And Accessories)
  1 report
• Mini ONE® Balloon Button M1-5-1212-I

  Tubes, Gastrointestinal (And Accessories)
  1 report
• Mini ONE® Balloon Button M1-5-1412-I

  Tubes, Gastrointestinal (And Accessories)
  1 report

Recent Mini ONE Balloon Button adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN MEDSUN REPORT #:(B)(4), IT WAS REPORTED THAT, "DURING SHIFT REPORT, DAY RN WAS TOLD THAT THE G TUBE WAS "LOOSE" AND COMMENTED ON BY PT'S MOTHER AND NURSE. PT'S SKIN SURROUNDING THE G TUBE IS ERYTHEMATOUS, EDEMATOUS, AND PAINFUL TO THE TOUCH. AT APPROX. 1300 BEDSIDE RN PERFORMED ROUTINE G [GASTRIC] TUBE CARES CONSISTING OF CLEANSING WITH NS AND GAUZE, APPLYING MANUKA HONEY, AND REAPPLYING TAPE-PER WOUND ORDER (NO TURNING). RN NOTED HOW LOOSE THE G TUBE WAS BUT SAFELY PERFORMED CARES. AFTERWARDS, AT APPROX 1315, RN ATTEMPTED TO OBTAIN A GIRTH, AT WHICH TIME THE PT BORE DOWN IN PAIN AND RN WITNESSED THE G TUBE BUTTON DISLODGE AND IMMEDIATELY CALLED THE NP [NURSE PRACTITIONER] TO BEDSIDE. UPON INVESTIGATING, IT WAS NOTED THAT THE G TUBE BALLOON HAD A PINHOLE LEAK IN IT AND WAS DEFLATED, VERIFIED BY THE OBSERVATION OF A LEAK WHEN INSTILLING NEW WATER INTO THE BALLOON".

  Patient problems: Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 23282564 ↗
• MalfunctionJun 13, 2025No Apparent Adverse Event; Material Split, Cut or Torn; No Apparent Adverse Event; Material Split, Cut or Torn

  PER THE ORIGINAL REPORTER IN MDR REPORT #: MW5170433, IT WAS REPORTED THAT,"ON (B)(6) 2025, THE INTERNAL BALLOON IN OUR DAUGHTER'S G TUBE (GASTROSTOMY TUBE) FAILED CAUSING IT TO BE DISLODGED. THIS REQUIRED US TO INSERT A FOLEY CATHETER AND TRAVEL TO THE EMERGENCY ROOM AT (B)(6) TO HAVE A NEW G TUBE INSERTED AND A FLUOROSCOPY TO CONFIRM PLACEMENT. IN THE TWO WEEKS SINCE SHE HAS HAD HER G TUBE, THIS IS THE SECOND TIME IT HAS FALLEN OUT DUE TO A MANUFACTURING DEFECT CAUSING THE INTERNAL BALLOON TO FAIL. THE FIRST TIME WAS ON (B)(6) 2025 WHILE SHE WAS STILL INPATIENT IN THE NEWBORN CRITICAL CARE CENTER. ON THAT TIME, SHE HAD TO WAIT 10 HOURS BETWEEN FEEDS DUE TO THE WAIT TO GET THE FLUOROSCOPY STUDY DONE TO CONFIRM PLACEMENT BEFORE SHE COULD BE FED AGAIN. AS A YOUNG INFANT, IT WAS VERY DISTRESSING FOR HER TO MISS MULTIPLE SCHEDULED FEEDS DUE TO THIS MANUFACTURING ERROR. WE WERE TOLD BY THE PEDIATRIC SURGERY TEAM AT (B)(6) THAT THEY CHECKED THE BALLOON AND THERE WAS A SMALL LEAK WHICH CAUSED IT TO FAIL. THEY SAID THEY HAVE CONTACTED THE MANUFACTURER IN THE PAST AND WERE TOLD THAT SOMETIMES THE LINING OF THE BALLOON IS SHAVED DOWN TOO FAR CAUSING IT TO FAIL PREMATURELY. THIS IS AN UNACCE

  Patient problems: Distress; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204499 ↗
• MalfunctionMar 17, 2025Material Separation; Material Separation

  PER THE ORIGINAL REPORTER IN UF #:(B)(4), IT WAS REPORTED THAT THE, "REGISTERED NURSE (RN) NOTED THAT MINIONE BALLOON BUTTON GASTRONOMY TUBE (GT) LIFTING SLIGHTLY TO ONE SIDE. TUBING TAPED TO PREVENT ANY TUGGING. SITE FLUSHED, NO LEAKING NOTED AT GT STOMA SITE. MEDICATIONS ADMINISTERED AT [TIME REDACTED]. RN FLUSHED AND NOTED NO LEAKING AT STOMA SITE. PULLED BACK FROM BALLOON INFLATION PORT AND NOTED 1ML GASTRIC CONTENT. GT BALLOON PORT INFLATED AND UNABLE TO PULL BACK POST INFLATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621385 ↗
• MalfunctionNov 7, 2024No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN UF #: (B)(4), IT WAS REPORTED THAT THE, "G-TUBE WAS DISCOVERED TO HAVE DISLODGED. UPON INVESTIGATION BY MEDICAL PERSONNEL, THE BALLOON WAS FOUND TO HAVE A HOLE AND HAD BECOME DEFLATED. THIS MADE IT SO THAT IT SLIPPED OUT BY ITSELF. THE G-TUBE WAS STILL CONSIDERED CRITICAL AND PATIENT HAD TO HAVE NEW G-TUBE PLACED BY SURGEON AT THE BEDSIDE. PATIENT WAS UNABLE TO GET NEEDED MEDS AND FOOD DURING THE TIME THAT THE G-TUBE WASN'T WORKING. IT WAS DISCOVERED WHEN MEDS AND FORMULA WERE FOUND TO HAVE MADE SWADDLE BLANKET WET".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631190 ↗
• MalfunctionSep 4, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A, "12 FR GT BALLOON DAMAGED AND LEAKING. SURGICAL TEAM TO BEDSIDE AND REPLACED GASTRONOMY TUBE (GT). FOLLOW-UP IMAGING REQUIRING TRANSPORTING PATIENT TO X-RAY FOR IMAGING STUDIES NEEDED. G-T SAVED IN BIOHAZARD BAG AND PLACED IN DEFECTIVE PRODUCT BIN. THIS IS THE SECOND INCIDENCE OF SOMETHING LIKE THIS HAPPENING FOR THIS PATIENT'S GT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135960 ↗
• MalfunctionFeb 20, 2024No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN UF #: (B)(4), IT WAS REPORTED THAT "DURING NURSING CARE, THE INFANT'S G-TUBE BUTTON FELL OUT. RN (REGISTERED NURSE) NOTED THE BALLOON WAS DEFLATED. SURGERY NP (NURSE PRACTITIONER) ASSESSED G-TUBE NOTING A SMALL HOLE IN THE BALLOON. BALLOON REMAINS DEFLATED SECURING G-TUBE IN PLACE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743352 ↗
• MalfunctionJan 4, 2024No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN UF/IMPOTER REPORT #: (B)(4), "LEAKAGE FROM THE CONNECTING PORT WAS NOTED ON THE PATIENT'S BLANKET. UPON INSPECTION, A CRACK WAS DISCOVERED AT THE PORT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445947 ↗
• InjuryDec 19, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  PER THE ORIGINAL REPORTER, THE BALLOON DEFLATED AFTER FIVE (5) DAYS OF USE AND THE PATIENT PRESENTED WITH FEVERS AND PERITONITIS, REQUIRING AN EMERGENCY LAPAROTOMY TO REPAIR THE STOMACH AND REPLACE THE GASTRIC TUBE. THE PATIENT WAS THEN TREATED WITH 7 DAYS OF ANTIBIOTICS AND IS NOW TOLERATING TUBE FEEDS.

  Patient problems: Fever; Peritonitis

  MAUDE report 18358613 ↗
• MalfunctionNov 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL MEDWATCH REPORT #: (B)(4). IT WAS REPORTED THAT "UPON CHECKING PLACEMENT OF GASTROSTOMY FEEDING TUBE, MILK LEAKAGE WAS FOUND ON PATIENT'S CLOTHING & BLANKET. BALLOON WAS CHECKED AND FOUND TO BE RUPTURED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194758 ↗
• MalfunctionNov 3, 2023No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN UF/IMPORTER REPORT #: (B)(4), "GASTROSTOMY TUBE BALLOON BROKE DURING INFLATION, TROCAR. PORTION OF TROCAR BROKE OFF DURING USE. PATIENT ADMITTED FOR LAPAROSCOPIC G TUBE. WHEN USING ELBOW ITEMS, AN ORANGE PIECE BROKE OFF TROCAR. ITEM RETRIEVED AND THE BUTTON ON THE G-TUBE BROKE OFF. ITEM RETRIEVED. NO HARM TO PATIENT. ITEMS GIVEN TO PURCHASING MANAGER [REDACTED NAME] FOR REVIEW WITH COMPANY. 5MM TROCAR REF# MS100705, LOT #P3E0261. GASTRIC BUTTON G TUBE REF# M1-5-1410-I, LOT #221210-042.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065491 ↗
• MalfunctionOct 12, 2023No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORT IN MDR #: MW5145075, "FAILED DEVICE: BUTTON MINIONE G-TUBE BALLOON BURST. PATIENT REQUIRED REPLACEMENT OF THE TUBE WITH WASHOUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928086 ↗
• MalfunctionOct 6, 2023No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN UF/IMPORTER REPORT #: (B)(4), "PATIENT'S MOM NOTICED PATIENT'S BUTTON PEG WAS LOOSE. WHEN SHE CHECKED THE BALLOON, IT WAS BROKEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887314 ↗
• MalfunctionSep 7, 2023

  PATIENT'S MOM NOTICED PATIENT'S BUTTON PEG WAS LOOSE. WHEN SHE CHECKED THE BALLOON, IT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698165 ↗
• MalfunctionJun 25, 2023No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER TO UF/IMPORTER REPORT #: (B)(4), IT WAS DOCUMENTED THAT "G-TUBE WAS FOUND TO BE DISLODGED FROM INFANT'S ABDOMEN. UPON INSPECTING THE MINI BUTTON, THE BALLOON WAS DEFLATED. TRIED TO REINFLATE THE BALLOON WITH STERILE WATER AND THE BALLOON WOULDN'T HOLD WATER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17196239 ↗
• MalfunctionJun 15, 2023No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN MEDWATCH REPORT #: (B)(4), IT WAS REPORTED THAT "DURING CHANGING OF TUBING EXTENSION SET, THE TUBE CAME OUT AND THE BALLOON WAS NOTED TO BE COMPLETELY DEFLATED. UPON INSTILLING WATER IN BALLOON, THERE WAS A LEAK FROM THE BALLOON IDENTIFIED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139462 ↗

Other Applied Medical Technology, Inc. products

• NutraGlide Nasal Feeding Tube8 models · 3 reports · 9 recalls
• AMT Mini Extension Set3 models · 6 reports · 1 recall
• AMT Mini ONE Extension Set5 models · 4 reports · 1 recall
• AMT Initial Placement Dilator Set2 models · 3 reports · 1 recall
• AMT Bridle4 models · 2 reports · 1 recall