Portex Z210-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019315046896), received between Sep 4, 2022 and Oct 26, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PRODUCT WAS DEFECTIVE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15673528 ↗
• MalfunctionSep 26, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THE CUSTOMER ATTEMPTED TO PASS IRRIGATION WATER THROUGH THE PRODUCT, BUT COULDN'T. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15487358 ↗
• MalfunctionSep 22, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THE CUSTOMER ATTEMPTED TO PASS IRRIGATION WATER THROUGH THE PRODUCT, BUT COULDN'T. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15465343 ↗
• MalfunctionSep 20, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS LEAKAGE INTO THE SLEEVE COVERING THE TUBE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457972 ↗
• MalfunctionSep 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THE CUSTOMER ATTEMPTED TO PASS IRRIGATION WATER THROUGH THE PRODUCT, BUT COULDN'T. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427018 ↗
• MalfunctionSep 4, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE SYSTEM WAS DIFFICULT TO INSTILL SALINE AND BUBBLES ACCUMULATE IN THE SYSTEM PROBE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353836 ↗