CARDIOSAVE BATTERY CHARGING STATION 0998-00-0802Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10607567111964), received between Feb 25, 2021 and Aug 26, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (1 report).

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

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. Feb 6, 2026Class IIIOpen, Classified

   The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.

   Z-1587-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Charging Problem

  It was reported that during installation the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) left side battery charger is not charging the batteries . No patient involvement. No harm was reported. The FSE reported that there are no servicable parts for charger. Could not complete repair on this device as no service parts are available for this device. The charging station still charges batteries in right bay. The FSE reported that repair/replacement of the charging station is NOT going to take place.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50445646 ↗
• MalfunctionSep 27, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS OVERHEATING ON A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17825060 ↗
• MalfunctionFeb 25, 2021Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT THE CARDIOSAVE BATTERY CHARGING STATION NEEDS TO BE RETURNED BECAUSE IS DIFFICULT FOR THE CUSTOMER TO REMOVE THE BATTERY PACK FROM ONE OF THE SLOTS. SINCE THIS IS AN ACCESSORY FOR THE IABP, THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 11381772 ↗