Flow Measurement Sensor ModuleRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04033817900733), received between Jun 29, 2023 and Jun 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K112225); 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.

• MalfunctionJun 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, PATIENT BLOOD FLOW WILL NOT CORRELATE WHEN THE RPM MAXS OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225143 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112225. One submission often covers many models, so check the product and lot details in each record.

• Z-0787-2022 · Dec 17, 2021 · Terminated
  Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control dev
• Z-0401-2018 · Oct 30, 2017 · Terminated
  CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sens
• Z-0857-2014 · Dec 4, 2013 · Terminated
  CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
• Z-1329-2012 · Feb 23, 2012 · Terminated
  Pump control panel. The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.