Salem Sump 8888266148 (UDI 10192253012842)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10192253012842), received between Jan 9, 2025 and Mar 3, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. Jul 24, 2024Class IIOpen, Classified

   The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.

   Z-3302-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Material Separation

  THE CUSTOMER REPORTED THAT THEY HAD A PATIENT WHO HAD HEART SURGERY. AFTER CHEST TUBE INSERTION, THE SALEM SUMP WAS INSERTED INTO EACH CHEST TUBE TO SUCTION THE DRAINAGE. AFTER STERNAL WIRING, THE SCRUB TECH WAS HAVING A PROBLEM PULLING THE SALEM SUMP FROM ONE OF THE CHEST TUBES. THE SURGEON TRIED TO PULL IT. THE TIP OF THE SALEM SUMP WAS NOTED MISSING WHEN IT CAME OUT. X-RAY WAS DONE BUT RADIOLOGIST WAS UNABLE TO VISUALIZE THE TIP. XRAY RESULT WAS RELAYED TO SURGEON. INCIDENT REPORT WAS MADE. PHOTO ATTACHED. PER ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 27FEB2026, THE SALEM SUMP WAS USED TO SUCTION THE DRAINAGE OF THE CHEST TUBE RIGHT AFTER INSERTION OF THE CHEST TUBES WHILE THE CHEST WAS STILL OPEN AND DURING STERNAL CLOSURE. THE MEASUREMENT ON THE TUBE SERVES AS GUIDE ON HOW FAR THE SUMP IS INSERTED INTO THE CHEST TUBE. IDEALLY THE SUMP NEEDS TO BE MOBILIZED DURING STERNAL WIRING. THEY STATE THIS IS ALSO A PRACTICE IN SOME HOSPITALS. ONCE THE CHEST IS CLOSED, THE SUMP IS REMOVED, THEN THE CHEST TUBE IS CONNECTED TO THE PLEURAVAC. UNFORTUNATELY, AFTER STERNAL WIRING, THE SCRUB PERSON COULD NOT REMOVE IT, SO THE SURGEON PULLED IT FORCEFULLY. THE TIP OF THE TUBE HAS NOT BE

  Patient problems: Insufficient Information

  MAUDE report 24501147 ↗
• MalfunctionJun 12, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE ANTI-REFLUX VALVE BROKE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025 STATED THAT THIS OCCURRED WHEN THE DEVICE WAS OPENED FOR TESTING, AND IT BROKE WHEN THEY TRIED TO INSERT AND REMOVE THE ARV FROM THE SUCTION TUBING PORT WHILE FOLLOWING THE INSTRUCTIONS INCLUDING MAKING SURE IT IS BEING REMOVED NOT ON AN ANGLE. IT SNAPPED CLEANLY AT THE BLUE JUNCTION (WHERE IT GOES FROM SMALL TO LARGE AND THEN IS ATTACHED TO THE WHITE). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22198709 ↗
• MalfunctionJun 12, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE ANTI-REFLUX VALVE BROKE. ADDITIONAL INFORMATION RECEIVED ON 06JUN2025 STATED THAT THIS OCCURRED WHILE IN USE IN A PATIENT FOR LESS THAN A FEW HOURS. IT SNAPPED CLEANLY AT THE BLUE JUNCTION (WHERE IT GOES FROM SMALL TO LARGE AND THEN IS ATTACHED TO THE WHITE). THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22198705 ↗
• MalfunctionJun 12, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE ANTI-REFLUX VALVE DISINTEGRATED/BROKE. ADDITIONAL INFORMATION RECEIVED ON 06JUN2025 STATED THAT THIS OCCURRED WHILE IN USE IN A PATIENT FOR LESS THAN A FEW HOURS. THE STAFF TRIED TO REMOVE IT WHOLLY FROM THE TUBING TO REPLACE WITH A NEW ARV, BUT IT KEPT BREAKING APART INTO SMALLER AND SMALLER PIECES UNTIL THEY ULTIMATELY HAD TO RESORT TO USING TWEEZERS TO TRY TO GET THE BITS OUT OF THE TUBING. IT BROKE AT THE WHITE JUNCTION, AND THEN CONTINUED TO CRUMBLE INTO FURTHER PIECES AS NURSING TRIED TO REMOVE IT FROM THE SALEM SUMP TUBING TO REPLACE. THERE WAS NO HARM TO THE PATIENT, HOWEVER IT WAS EXTREMELY DIFFICULT TO REMOVE THE BROKEN ENDS FROM THE TUBING AND REQUIRED KELLY CLAMPS AND TWEEZERS OTHER INTERVENTIONS TO BE ABLE TO, BUT STAFF REPORTED THEY MANAGED TO CORRECT THE SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22198696 ↗
• MalfunctionJan 9, 2025Break; Break

  THE CUSTOMER REPORTED WHEN USING THE ANTI-REFLUX VALVE WITH THE NG TUBE, THEY ARE BREAKING WHEN THEY ATTEMPT TO REMOVE THEM FROM THE TUBE. THEY HAVE HAD THIS HAPPEN MULTIPLE TIMES NOW SO THEY ARE THINKING IT MAY BE A PRODUCT ISSUE INSTEAD OF A USER/FLUKE THING. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2025, THEY WERE UNABLE TO REMOVE THE ARV FROM THE TUBE SO THEY HAD TO REMOVE AND RE-INSERT ANOTHER NG TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114450 ↗