CS100 Intra-Aortic Balloon Pump, Refurbished, PORTUGUESE,NON-UTS,INTL 0998-UC-3013-69Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10607567112596), received between Aug 10, 2022 and May 8, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (2 reports).

8 other recalls cover devices cleared under the same FDA submission (K031636); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2025Electrical /Electronic Property Problem; Unexpected Shutdown; Electrical /Electronic Property Problem; Unexpected Shutdown

  IT WAS REPORTED THAT DURING ROUTINE TESTING THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) WAS SHOWING "SYSTEM FAILURE" ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21984049 ↗
• MalfunctionJan 9, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479001 ↗
• MalfunctionJan 24, 2023Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) AUTOFILL FAILED.

  Patient problems: Insufficient Information

  MAUDE report 16233625 ↗
• MalfunctionJan 9, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT NEEDS CORRECTIVE MAINTENANCE.

  Patient problems: Insufficient Information

  MAUDE report 16127948 ↗
• MalfunctionNov 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 15735208 ↗
• MalfunctionOct 3, 2022Erratic or Intermittent Display; Suction Problem; Device Displays Incorrect Message; Erratic or Intermittent Display; Suction Problem; Device Displays Incorrect Message

  IT WAS REPORTED THAT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNITS SCREEN IS WITH TREMORS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527495 ↗
• MalfunctionAug 10, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNITS DISPLAY HAD INTERFERENCE. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE EVENT OCCURRED OR IF THERE WAS ANY PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204162 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031636. One submission often covers many models, so check the product and lot details in each record.

• Z-1486-2026 · Jan 23, 2026 · Open, Classified
  CS100 IABP. Software Version CS100 IABP Q.01.
• Z-3086-2017 · Jul 17, 2017 · Open, Classified
  CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by au
• Z-3085-2017 · Jul 17, 2017 · Open, Classified
  CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by a
• Z-2737-2017 · Jun 16, 2017 · Terminated
  CS 100 Intra-Aortic Balloon Pump
• Z-2736-2017 · Jun 16, 2017 · Terminated
  CS 100i Intra-Aortic Balloon Pump
• Z-1523-2014 · Mar 21, 2014 · Terminated
  Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate in
• Z-2414-2011 · Mar 16, 2011 · Terminated
  Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 130
• Z-1811-2010 · May 10, 2010 · Terminated
  CS100 Intra-Aortic Balloon Pump.