CP5 Pump Control Panel (UDI 04033817902782)Recalls & reported problems
LivaNova Deutschland GmbH · Class 2
All models of CP5 (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04033817902782), received between Apr 19, 2023 and Sep 16, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem2
- Pumping Problem2
- Pumping Stopped2
- Complete Loss of Power1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Insufficient Device Problem Information1
- Insufficient Flow or Under Infusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Complete Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50783874 ↗MalfunctionDec 24, 2025Pumping Problem; Pumping Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23886736 ↗MalfunctionNov 6, 2024Pumping Stopped; Pumping Stopped
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20619380 ↗MalfunctionDec 19, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18356288 ↗MalfunctionDec 12, 2023Pumping Stopped; Pumping Stopped
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CENTRIFUGAL PUMP 5 (CP5) STOPPED DURING PROCEDURE WHEN TURNING DOWN FLOW. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18309144 ↗MalfunctionDec 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18299180 ↗MalfunctionJul 20, 2023Pumping Problem; Pumping Problem
SEE INTIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17359202 ↗MalfunctionJun 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Infusion or Flow Problem; Incorrect, Inadequate or Imprecise Result or Readings; Infusion or Flow Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17216958 ↗MalfunctionApr 19, 2023Infusion or Flow Problem; Infusion or Flow Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CENTRIFUGAL PUMP 5 (CP5) GAVE A MOTOR CONTROL FAILURE MESSAGE AT SETUP. TURNING OFF AND ON THE DEVICE, THE ERROR MESSAGE DISAPPEARED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16767217 ↗
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 · TerminatedSorin 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 · TerminatedCP5 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 · TerminatedCP5 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 · TerminatedPump 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.
Other Control, pump speed, cardiopulmonary bypass devices
- 2nd Gen CentriMag Primary Console 201-90411Thoratec Switzerland GmbH · Control, Pump Speed, Cardiopulmonary Bypass1 recall459 reports
- NA 560BCS1Medtronic, Inc. · Control, pump speed, cardiopulmonary bypass1 recall135 reports
- Bio-Console® 560BCS1Medtronic, Inc. · Control, pump speed, cardiopulmonary bypass1 recall129 reports
- Bio-Console® 560BCS1Medtronic, Inc. · Control, pump speed, cardiopulmonary bypass1 recall1 death121 reports
- LifeSPARC 5900-0001Cardiacassist, Inc. · Control, Pump Speed, Cardiopulmonary Bypass2 recalls1 death5 reports
- CP5 Pump Control PanelLivaNova Deutschland GmbH · Control, pump speed, cardiopulmonary bypass1 recall53 reports
- LifeSPARC 5900-0000Cardiacassist, Inc. · Control, Pump Speed, Cardiopulmonary Bypass2 recalls0 reports
- CP5 Drive UnitLivaNova Deutschland GmbH · Control, pump speed, cardiopulmonary bypass1 recall32 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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