C5 SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04033817900924), received between Sep 4, 2018 and Sep 26, 2018 — classified as 2 malfunctions.

7 other recalls cover devices cleared under the same FDA submission (K093882); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A C5 SYSTEM DISPLAYED A WARNING MESSAGE DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7909321 ↗
• MalfunctionSep 4, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A C5 SYSTEM DISPLAYED AN ERROR MESSAGE DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7841242 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093882. One submission often covers many models, so check the product and lot details in each record.

• Z-0856-2014 · Dec 4, 2013 · Terminated
  S5/C5 Heart-lung machine 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-0272-2013 · Sep 19, 2012 · Terminated
  S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0271-2013 · Sep 19, 2012 · Terminated
  S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0275-2013 · Sep 19, 2012 · Terminated
  Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0273-2013 · Sep 19, 2012 · Terminated
  S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0274-2013 · Sep 19, 2012 · Terminated
  S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-1330-2012 · Feb 23, 2012 · Terminated
  Sorin C5 (perfusion system) The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.