System, Gastrointestinal Motility (Electrical)

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-07-02Open, ClassifiedDevice Design

  Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p, Trolley system (G3-14);

  Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed.

• 2025-08-14Open, ClassifiedError in labeling

  Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

  Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.

• 2023-09-07Open, ClassifiedLabeling Change Control

  ZVU Functional GI Software, REF: ZVU-3

  GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

• 2012-05-07TerminatedSoftware change control

  Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal studies as an aid in documenting and diagnosing digestive motility disorders.

  Software error may produce incorrect esophageal contraction readings.

• 2011-10-28TerminatedNonconforming Material/Component

  AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, Box label: LBL-110282-03, Package Inserts: DOC-3682, User Manual: DOC-1332-12. Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.

  The recall was initiated after Given Imaging received a test report during a Canadian licensing process where the AR ManoShield exhibited pinholes and did not pass the test, the Field Safety Corrective Action (FSCA) Committee was convened. As a result of the data discussed during this meeting, a decision was made to voluntarily recall this product, and cease its further commercialization or distr

• 2004-07-20TerminatedOther

  Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081

  Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.