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Salem Sump 8888264986 (UDI 10884521007734)Recalls & reported problems

Cardinal Health, Inc. · Dual Lumen Stomach Tube · Class 2

All models of Salem Sump (28)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521007734), received between Mar 15, 2017 and Aug 19, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Device problems

  • Detachment of Device or Device Component1
  • Kinked1

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT THE TIP APPEARS TO BE THINNER THAN THE REST OF THE CATHETER AND IS BREAKING OFF. THERE WAS NO HARM TO THE PATIENT. THE CUSTOMER STATED THIS HAS HAPPENED TO OTHERS THEY HAVE OPENED AS WELL.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8905458 ↗
  • MalfunctionMar 15, 2017Kinked; Kinked

    THE CUSTOMER REPORTS THE SUMP TUBE SEEMED TO NARROW OR COLLAPSE WHEN FEEDING.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6405950 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

Sources and updates

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