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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98432

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 06, 2026
Product types
Device
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Datascope Corp.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Battery Charging Station; Model: 0998-00-0802;

Z-1587-2026
Recall number
Z-1587-2026
Initiated
February 06, 2026
Classification
Class III
Status
Ongoing
Recalling firm
Datascope Corp.
Quantity
28 units (20 US, 8 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Model: 0998-00-0802; UDI: 10607567111964; Serial Numbers: 200019347EAI, 200019847EAI, 200019447EAI, 210018625EAI, 210017925EAI, 210017525EAI, 210018425EAI, 210020144EAI, 210020944EAI, 210022544EAI, 210020244EAI, 210022144EAI, 210020044EAI, 210020544EAI, 210021344EAI, 210023244EAI, 210018025EAI, 210019025EAI, 210021144EAI, 210021044EAI, 210022344EAI, 210019225EAI, 210019125EAI, 210018525EAI, 210022844EAI, 200017647EAI, 210019725EAI, 210022744EAI;

Distribution pattern

Worldwide - US Nationwide distribution in the states of FL, DC, GA, IL, IN, MD, MI, NC, TX, WA, WI and the countries of Australia, Hong Kong, Israel, Japan, Norway.