CS100 Intra-Aortic Balloon Pump, Spanish, 220V 0998-00-3013-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10607567107622), received between Feb 15, 2021 and Jan 6, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 23, 2023Class IIOpen, Classified

   During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

   Z-2216-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Charging Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) BATTERIES DO NOT HOLD FOR TRANSPORT. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973472 ↗
• MalfunctionAug 19, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22836861 ↗
• MalfunctionJun 16, 2025Inability to Auto-Fill; Inability to Auto-Fill

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

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

  MAUDE report 22211420 ↗
• MalfunctionJun 11, 2025Battery Problem; Battery Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DURING ROUTINE CHECK, CS100 INTRA-AORTIC BALLOON PUMP (IABP) FAILED BATTERY TEST. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182055 ↗
• MalfunctionJun 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182054 ↗
• MalfunctionDec 3, 2024Inability to Auto-Fill; Inability to Auto-Fill

  N/A

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

  MAUDE report 20835834 ↗
• MalfunctionOct 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAS A CORONARY UNIT ERROR.

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

  MAUDE report 20538102 ↗
• MalfunctionOct 18, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) SCREEN DOES NOT WORK. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 20485662 ↗
• MalfunctionMay 22, 2024Battery Problem; Battery Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369729 ↗
• MalfunctionApr 4, 2024Break; Break

  IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A BROKEN ECG CABLES.

  Patient problems: Insufficient Information

  MAUDE report 19042614 ↗
• MalfunctionApr 3, 2024Inability to Auto-Fill; Decrease in Suction; Inability to Auto-Fill; Decrease in Suction

  IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN AUTOFILL FAILURE AND LOW VACUUM LEVEL.

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

  MAUDE report 19031025 ↗
• MalfunctionMar 4, 2024Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED THAT BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) CAUSED A FILLING FAILURE WHEN CONNECTED. THERE WAS NO PATIENT INVOLVED.

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

  MAUDE report 18832481 ↗
• MalfunctionJan 17, 2024Break; Break

  IT WAS REPORTED THAT BEFORE USE THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAS A BROKEN CABLE . THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525831 ↗
• MalfunctionJan 5, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD MASSIVE ENTRY OF BLOOD INTO THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18456425 ↗
• MalfunctionDec 28, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE BY GETINGE FIELD SERVICE ENGINEER, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT'S POWER BUTTON SOMETIMES FAILS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18413890 ↗
• MalfunctionDec 22, 2023Break; Break

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18382347 ↗
• MalfunctionNov 14, 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 HAD AN OPERATION CHECK.

  Patient problems: Insufficient Information

  MAUDE report 18131976 ↗
• MalfunctionOct 31, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD ELECTRICAL TEST FAILURE, CODE NO. 65. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 18038020 ↗
• MalfunctionOct 3, 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) DOES NOT WORK.

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

  MAUDE report 17864237 ↗
• MalfunctionAug 8, 2023Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD DAMAGE TO HELIUM BOTTLE SUPPORT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17478796 ↗
• MalfunctionApr 24, 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) UNITS HELIUM NEEDED REPLACING.

  Patient problems: Insufficient Information

  MAUDE report 16797782 ↗
• MalfunctionMar 27, 2023Noise, Audible; Noise, Audible

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16617732 ↗
• MalfunctionNov 22, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS MISSING A TAB TO BE ABLE TO OPEN SIDE STORAGE DRAWER.

  Patient problems: Insufficient Information

  MAUDE report 15847903 ↗
• MalfunctionNov 9, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) DOES NOT WORK.

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

  MAUDE report 15758663 ↗
• MalfunctionApr 26, 2022Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A BLOOD STOP ERROR. IT IS UNKNOWN THE CIRCUMSTANCES UNDER WHICH THE EVENT OCCURRED. IT IS ALSO UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14208283 ↗

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-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-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-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.