Salem Sump 8888264986ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521779457), received between Nov 3, 2023 and Aug 4, 2025 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Obstruction of Flow” (1 report).

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-0206-2026 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• DeathAug 4, 2025Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED AN INSERTION ON (B)(6) 2025 OF A NASOGASTRIC TUBE ON A PATIENT WHO WAS POORLY RELIEVED. THE PATIENT WAS TRANSFERRED TO IMAGING FOR A CT SCAN TO IDENTIFY THE CAUSE OF THE OCCLUSION. PERSISTENCE OF VOMITING ON CT SCAN WITH MASSIVE INHALATION RESPONSIBLE FOR CARDIOPULMONARY ARREST NOT RECOVERED IN RADIOLOGY. IN ALL LIKELIHOOD, THE SUCTION OF THE NASOGASTRIC TUBE WAS UNSATISFACTORY DUE TO THE LACK OF OPENING OF THE AIR INTAKE SYSTEM. INDEED, IN THE ABSENCE OF AN ANTI-BACKFLOW VALVE, THE ENFIT CONNECTOR HAS BEEN CONNECTED TO THE PROBE, WITH THE CAP CLOSED. CURRENT PATIENT CONDITION: ABSENCE OF SUCTION FOR SEVERAL HOURS. CARDIOPULMONARY ARREST FOLLOWED BY THE PATIENT'S DEATH. ON (B)(6) 2025, (B)(6) CARDINAL HEALTH SALES REP, REPORTED SHE HAD A DISCUSSION WITH CUSTOMER, (B)(6), HEAD NURSE AND CONFIRMED THERE WERE NO PROBLEMS WITH THE DEVICE. INSTEAD, THERE WAS A LACK OF KNOWLEDGE ON THE PART OF SOME CAREGIVERS. ADDITIONAL PRODUCT TRAINING WILL BE PROVIDED BY CARDINAL HEALTH SALES TEAM. THE SALES REP ALSO STATED THAT THE CAPPED ENFIT WAS IN THE BLUE PORT. THE FACILITY DID NOT HAVE ACTIVE SUCTION HOOKED UP TO THE CLEAR PART OF THE TUBE. THEY HAD GOTTEN RETURN OF STOMAC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aspiration/Inhalation; Vomiting

  MAUDE report 22709105 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE TUBE WAS TOO RIGID AND DID CAUSE A GASTRIC PERFORATION; APPROXIMATELY 1-WEEK POST-INSTALLATION, BILE DETECTED IN ABDOMINAL DRAINS. UPON SURGICAL RE-EXPLORATION, A PERFORATION OF THE STOMACH WAS NOTED. SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.

  Patient problems: Internal Organ Perforation

  MAUDE report 18066592 ↗