Medivators Hookup (REF 28511)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00677964066726), received between Mar 7, 2024 and Mar 7, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K102996, K172677); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 13, 2023Open, Classified

   Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.

   Z-0617-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2024Device Difficult to Setup or Prepare; Insufficient Device Problem Information; Device Difficult to Setup or Prepare; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA MEDWATCH REPORT # 4400480000-2023-8027 THAT, "THE PATIENT NEEDED AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) RELATED TO EPIGASTRIC PAIN, GASTRITIS WITHOUT BLEEDING, AND UNSPECIFIED ABDOMINAL PAIN. STAFF TRIED TWICE TO LOAD THE ADVANTAGE MEDIVATOR TO PREPARE SUPPLIES, BUT THE MACHINE MALFUNCTIONED AND ALARMED ON TWO SEPARATE ATTEMPTS RESULTING IN INABILITY TO PERFORM PROCEDURE. PATIENT WAS MONITORED OVER NIGHT AND DISCHARGED TO RECEIVE PROCEDURE AT AN OUTPATIENT CLINIC IN THE AREA." NO REPORT OF INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862803 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102996, K172677. One submission often covers many models, so check the product and lot details in each record.

• Z-2537-2024 · Jun 13, 2024 · Open, Classified
  Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru
• Z-2538-2024 · Jun 13, 2024 · Open, Classified
  Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru
• Z-2536-2024 · Jun 13, 2024 · Open, Classified
  Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Au