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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67815

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

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Event summary

Timeline bucket
March 21, 2014
Product types
Device
Classifications
Class I
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

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 intra-aortic balloons in cardiovascular procedures.

Z-1523-2014
Recall number
Z-1523-2014
Initiated
March 21, 2014
Classification
Class I
Status
Terminated
Quantity
11,881 units (US 5183 and OUS 6698)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
assembly failure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.

Code information

IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx

Distribution pattern

Worldwide Distribution - USA (nationwide) and approximately 104 countries.