ICU Medical 50328 (REF 50328-07)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619059835), received between May 14, 2019 and May 14, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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.

• MalfunctionMay 14, 2019Positioning Failure; Positioning Failure

  USER FACILITY MEDWATCH WAS RECEIVED THAT STATED THE FOLLOWING: ¿ANESTHESIA PROVIDER WAS INSERTING A PULMONARY ARTERY CATHETER WHEN IT BECAME DIFFICULT TO RETRACT. THE CATHETER COULD BE ADVANCED, JUST NOT RETRACTED. THE INABILITY TO PLACE THE CATHETER IN THE DESIRED ANATOMICAL POSITION RESULTED IN THE ANESTHESIA PROVIDER ATTEMPTING TO WITHDRAW THE CATHETER. THE CATHETER COULD NOT BE DISCONTINUED AND REMOVED WITHOUT THE CORDIS AS WELL¿. IT WAS ALSO REPORTED THAT THE EVENT OCCURRED DURING INSERTION OF A PULMONARY ARTERY CATHETER. THERE WAS NO ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609087 ↗

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-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
• 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-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