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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70510

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

Open FDA event record

Event summary

Timeline bucket
January 30, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Maquet Datascope Corp - Cardiac Assist Division

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

Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

Z-1140-2015
Recall number
Z-1140-2015
Initiated
January 30, 2015
Classification
Class II
Status
Terminated
Quantity
1,300 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Power supply malfunction complaints related to suboptimal thermal management.

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

Power supply malfunction complaints related to suboptimal thermal management.

Code information

0998-00-0800-31 0998-UC-0800-31 0998-00-0800-32 0998-UC-0800-33 0998-00-0800-33 0998-UC-0800-52 0998-00-0800-34 0998-UC-0800-53 0998-00-0800-35 0998-UC-0800-55 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55. CARDIOSAVE Hybrid IABPs serviced with a new/replacement power supply after August 19, 2014 are not affected.

Distribution pattern

US Nationwide distribution

Field note

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