Salem Sump 266148Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521065055), received between Jul 28, 2022 and Feb 10, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

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.

Recalls naming this device

1. Sep 18, 2025Class IIOpen, Classified

   Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

   Z-0210-2026 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Break; Break

  THE CUSTOMER REPORTED THE GASTRIC FLUID WAS NOT DRAINED, EVEN IF THE MEASUREMENT WAS CORRECT. THE REPORTER DOES NOT KNOW IF THE PERSON WHO INSERTED THE TUBE CHANGED THE TUBE AND SAW A DIFFERENCE. FOR THE RETURN TO SURGERY, IT WAS NOTED WHEN THE VALVE HAD TO BE REMOVED TO FLUSH THE AIR INTAKE, THE VALVE BROKE IN TWO. PER THE NURSE, THE PROCEDURE WAS PERFORMED DURING A WEEKEND IN THE EMERGENCY DEPARTMENT BETWEEN (B)(6) 2025. THERE WAS NO CONSEQUENCE ON THE PATIENT. UNFORTUNATELY, NO MORE INFORMATION IS AVAILABLE REGARDING HOW THE SALEM TUBE HAS BEEN USE OR ABOUT THE PATIENT THEMSELF. PER ADDITIONAL INFORMATION PROVIDED BY THE NURSE ON (B)(6) 2025, WHEN THEY STATE "FOR THE RETURN TO SURGERY" THEY ARE REFERRING TO THE RETURN OF THE CATHETER ASSESSMENT BY THE NURSE IN THE SURGERY DEPARTMENT. THE PATIENT DID NOT CHANGE LOCATIONS OF THE HOSPITAL BETWEEN THE TIME THE CATHETER WAS INSERTED AND THE TIME THE VALVE BROKE. THE CATHETER HAD BEEN IN PLACE FOR 48 TO 72 HOURS MAXIMUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343691 ↗
• MalfunctionOct 23, 2024Separation Failure; Separation Failure

  THE CUSTOMER REPORTED THERE IS A FILTER ON THE AIR INTAKE OF THESE PROBES THAT PREVENTS SECRETION FROM BEING SUCKED IN. THIS FILTER (ANTI-REFLUX VALVE) SEEMS TO BE REMOVABLE BUT IT WAS IMPOSSIBLE TO REMOVE IT AT ALL. IT IS NOT SAFE. IT WAS IMPOSSIBLE TO EMPTY THE GASTRIC CONTENTS OF THE STOMACH. THE SALEM SUMP NEEDED TO BE REMOVED FROM THE PATIENT AND REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517865 ↗
• MalfunctionJun 12, 2024Break; Break

  THE CUSTOMER REPORTED THAT WHEN USING THE TUBE, THE TIP GETS STUCK IN THE CATHETER AND POSSIBILITY OF CLOSING OR GENTLY SUCTIONING THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT REPEATED CONNECTION/DISCONNECTION OF THE VALVE WAS THE SOURCE OF THE VALVE BREAK PROBLEM. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524671 ↗
• MalfunctionJul 28, 2022Material Twisted/Bent

  THE CUSTOMER REPORTED THE PROBE BENT IN THE ESOPHAGUS. THE PROBE WAS REPOSITIONED AND REMAINED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15121562 ↗