SCP Drive UnitRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04033817900931), received between May 24, 2018 and Dec 22, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, THE SCP PUMP KEEPS RESETTING THE RPM TO 1000 AND DISPLAYS ERROR EPROM DEFECTIVE (E04). THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387629 ↗
• MalfunctionApr 19, 2023Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THERE WAS A FLOW DROPPING ON CENTRIFUGAL PUMP SYSTEM WHEN ROTATION PER MINUTE (RPM) WAS AT ITS MAXIMUM. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16767219 ↗
• MalfunctionJun 28, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP DISPLAYED AN ERROR MESSAGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8743008 ↗
• MalfunctionFeb 14, 2019Appropriate Device Problem Term/Code Not Available; Noise, Audible; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  SEE INITIAL.

  Patient problems: No Patient Involvement

  MAUDE report 8339141 ↗
• MalfunctionMay 24, 2018Pumping Stopped; No Flow; Pumping Stopped; No Flow

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP DID NOT DISPLAY FLOW DURING A PROCEDURE. THE CUSTOMER REPORTED THAT THE PUMP DID NOT TURN AND THAT THE EMERGENCY DRIVE WAS UTILIZED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7543238 ↗

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