Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92498

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 31, 2023
Product types
Device
Classifications
Class I
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

2 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 2

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65, 0998-00-0800-36, 0998-UC-0800-32, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-65,

Z-2433-2023
Recall number
Z-2433-2023
Initiated
July 31, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Datascope Corp.
Quantity
11574 units (5413 US, 6161 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

Code information

All Lot Numbers. Model: 0998-00-0800-31, UDI: 10607567109053; Model: 0998-UC-0800-31, UDI: N/A; Model: 0998-00-0800-32,UDI: 10607567111117; Model: 0998-00-0800-33, UDI: 10607567109008; Model: 0998-UC-0800-33, UDI: N/A; Model: 0998-00-0800-34, UDI: 10607567111940; Model: 0998-00-0800-35, UDI: 10607567109107; Model: 0998-00-0800-45, UDI: 10607567108421;Model: 0998-00-0800-52, UDI: 10607567108438; Model: 0998-UC-0800-52, UDI: N/A; Model: 0998-00-0800-53, UDI:10607567108391; Model: 0998-UC-0800-53, UDI: N/A; Model: 0998-00-0800-55, UDI: 10607567108414; Model: 0998-UC-0800-55,UDI: N/A; Model: 0998-00-0800-65, UDI: 10607567113432; Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449; Model: 0998-00-0800-36, UDI: 10607567114187; Model: 0998-UC-0800-32, UDI: N/A; Model: 0998-UC-0800-34, UDI: N/A; Model: 0998-UC-0800-35, UDI: N/A; Model: 0998-UC-0800-36, UDI: N/A; Model: 0998-UC-0800-45, UDI: N/A; Model: 0998-UC-0800-65, UDI: N/A;

Distribution pattern

Worldwide - US Nationwide distribution.

device · product 2 of 2

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,

Z-2434-2023
Recall number
Z-2434-2023
Initiated
July 31, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Datascope Corp.
Quantity
47 units (42 US, 5 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

Code information

All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449, Model: 0998-UC-0800-75, UDI: N/A; Model: 0998-UC-0800-83, UDI: N/A; Model: 0998-UC-0800-85, UDI: N/A;

Distribution pattern

Worldwide - US Nationwide distribution.