Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Number 801046, Terumo Cardiovascular Systems, Ann Arbor, MI 48103

FDA Recall Z-0323-2008 · Posted 2007-12-01

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTQ
Date Initiated2007-09-10
Date Terminated2009-07-07
Product Quantity120

Reason for Recall

Failure to operate: The unit display may go blank and reset when the start button is pressed, due to an internal electrical short, resulting in a centrifugal pump that fails to start as expected.

Firm Action

Consignees were notified via an Urgent Medical Device Correction letter dated 9/10/07, given instructions to follow if the problem were to manifest itself, and informed the firm would contact them to schedule an upgrade.

Root Cause

Component change control

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022947ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCHTerumo Cardiovascular Systems Corp. · 2003-03-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑