ICU Medical 50328 (REF 50328-08)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619059842), received between Oct 24, 2024 and Oct 24, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K091268); they may or may not involve this specific model.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MARCH OF 2024 AND INVOLVED A TRIOX¿ SVO2 PA CATHETER P7110-EP8-H, 8F, 110CM, EXTRA PORT, HEPARIN COATED, LF (SWAN-GANZ). THE DEVICE WAS PLACED IN THE CATH LAB AND 2 OF THE 3-WAY STOPCOCKS FAILED. ONE WAS ON THE INFUSION PORT AND THE OTHER WAS ON THE PULMONARY ARTERY (PA) LINE WHICH CAUSED BLOOD TO BACK UP. BOTH LEAKED FROM A CRACK/HOLE ON THE SIDE OF THE "T". THE ORIGINAL INTENDED PROCEDURE WAS PULMONARY ARTERY CATHETER MONITORING. THIS IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT. APPROXIMATE AGE OF DEVICE: 1 DAY. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20523025 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091268. One submission often covers many models, so check the product and lot details in each record.

• Z-2001-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-1999-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-2000-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-1997-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-1998-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p