inforMED
DWCClass IILife-sustaining

Controller, Temperature, Cardiopulmonary Bypass

Cardiovascular · 21 CFR 870.4250

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

MDR events9,165All time
Recalls52All time
Registered firms14Currently listed
510(k) clearances30All time

Recent MDR events

9,165 adverse event reports on file

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Event type breakdown

Malfunction7,957
Injury627
Unspecified298
Death204
Other79

Most-reported manufacturers

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Livanova Deutschland3,425Cardioquip, Llc1,305Terumo Cardiovascular Systems Corp.1,227Livanova Deutschland Gmbh673Maquet Cardiopulmonary Ag655Sorin Group Deutschland538Terumo Cardiovascular Systems Corporation161Terumo Cardiovascular System Corp134

Recalls

52 recall events for this product code

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Registered firms

14 firms currently registered for this product code

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510(k) clearances

30 clearances for this product code

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