AspireAssist A-Tube Kit 100-0011-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10857808005471), received between Jan 29, 2019 and Jan 6, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2020Material Integrity Problem; Material Integrity Problem

  PATIENT IS (B)(6) FEMALE WITH A HISTORY OF OBESITY UNDERGOING ASPIRE ASSIST THERAPY, A-TUBE PLACEMENT IN (B)(6) OF 2018. RN REPORTED BEING CONTACTED BY A PATIENT WHO STATED THAT THE SKIN PORT HAD COME OFF AND THE A-TUBE HAD RETRACTED INTO THE STOMACH.

  Patient problems: Missing Value Reason

  MAUDE report 9554017 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH GASTROSTOMY TUBE (A-TUBE). APPROXIMATELY 6 WEEKS LATER PRESENTED WITH HEPATIC ABSCESS SECONDARY TO STREP INTERMEDIUS INFECTION.

  Patient problems: Abscess

  MAUDE report 9488413 ↗
• MalfunctionJan 29, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  [PATIENT (B)(6)] IS A (B)(6) YEAR OLD FEMALE WITH HISTORY OF OBESITY WITH ASPIRE DEVICE PLACEMENT IN (B)(6) 2014 (REPLACEMENT IN (B)(6) 2017) WHO PRESENTS TO THE ED WITH BROKEN DEVICE. SHE STATES THAT SHE WAS DOING ROUTINE DRAINAGE OF STOMACH CONTENTS THIS MORNING AND THE EXTERNAL DEVICE FRACTURED. SHE THEN HAD LEAKAGE OF STOMACH CONTENTS. OTHERWISE, SHE DENIES NAUSEA, VOMITING, FEVERS, CHILLS, DIARRHEA, OR CONSTIPATION. IN THE ED, PATIENT HAD GI CONSULT AND SHE WAS TRANSFERRED TO THE EDOU TO AWAIT OR FOR REMOVAL OF BROKEN DEVICE. PATIENT TO THE OPERATING ROOM AND HAD EGD AND REMOVAL OF BROKEN DEVICE. PATIENT TO FOLLOW UP OUTPATIENT WITH GASTROENTEROLOGY KNOWN TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8285843 ↗