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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72890

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

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Event summary

Timeline bucket
December 16, 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

Cardiosave Hybrid and rescue IABP

Z-1248-2016
Recall number
Z-1248-2016
Initiated
December 16, 2015
Classification
Class II
Status
Terminated
Quantity
1243 units US; 1107 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.

Code information

Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83

Distribution pattern

Worldwide Distribution- Nationwide Distribution including Puerto Rico.