Flow Measurement Sensor Sorin 3/8" x 3/32"Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04033817901532), received between Sep 29, 2017 and Nov 20, 2024 — classified as 2 malfunctions.

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

4 other recalls cover devices cleared under the same FDA submission (K011838); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING PRIMING, WHEN THE BLOOD FLOW RATE IS 0, THE CP5 FLOW SENSOR DISPLAY SHOWS 200ML TO 300ML AND THE FLOW IS UNSTABLE. THERE WAS NO PATIENT INVOLVEMENT. THE DISPLAY RETURNED TO NORMAL WHEN IT WAS REPLACED IT WITH A BACKUP SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20732989 ↗
• MalfunctionSep 29, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  LIVANOVA (B)(4) RECEIVED A REPORT THAT THE SCP FLOW SENSOR 3/8" DISPLAYED A FLOW RATE DEVIATION OF -0.9L/MIN WHEN COMPARED TO THE ACTUAL FLOW RATE DURING A PROCEDURE. THE SYSTEM WAS REBOOTED SEVERAL TIMES AND THE SENSOR WAS DISCONNECTED AND RE-CONNECTED, BUT THE ISSUE PERSISTED. THE SENSOR WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6903652 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011838. One submission often covers many models, so check the product and lot details in each record.

• Z-2439-2020 · Aug 26, 2019 · Terminated
  Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
• Z-2440-2020 · Aug 26, 2019 · Terminated
  Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
• Z-0167-2013 · Sep 20, 2012 · Terminated
  SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device
• Z-0166-2013 · Sep 20, 2012 · Terminated
  SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated