Z-0299-2012

The Terumo Advanced Perfusion System 1, Catalog Number 801764 System 1 Base, 220 V

Name: Z-0299-2012 The Terumo Advanced Perfusion System 1, Catalog Number 801764 System 1 Base, 220 V
Creator: Terumo Cardiovascular Systems Corporation
Published: 2011-11-08
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-11-08 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of The Terumo Advanced Perfusion System 1, Catalog Number 801764 System 1 Base, 220 V Product Usage: The Advanced Perfusion System 1 is indicated for use for up... on 2011-11-08. The reason FDA records is "1 US customer was operating the Advanced Perfusion System 1 with an unapproved, modified cable, which was in product development, to connect the system an an occluder for the Sarns Modular Perfusion System 8000...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0299-2012
Status: Terminated
Initiated: 2011-11-08
Posted: 2011-11-29
Terminated: 2012-08-22
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: The Terumo Advanced Perfusion System 1, Catalog Number 801764 System 1 Base, 220 V Product Usage: The Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: 1 US customer was operating the Advanced Perfusion System 1 with an unapproved, modified cable, which was in product development, to connect the system an an occluder for the Sarns Modular Perfusion System 8000 . Five(5)of twelve(12) cables from Terumo Japan, which were in product development, were given to a US customer.
Root cause tag: design
FDA root cause: Component design/selection
Action: Terumo sent an URGENT MEDICAL DEVICE CORRECTION: Recall Notification dated November 8, 2011 to all affected customers. The letter described the reason for the recall, known/potential hazards and request immediate location and correction of product. The letter instructs customers to stop using the modified cables and return to Terumo for replacement and destruction. Customers were asked to complete the attached response form and fax to the number indicated on the form. All affected customers will be receiving a safety advisory to advise them that Terumo do not recommend the alternative configuration of a System 1 Base with an 8K Occluder. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818 or 1-800-292-6551 (fax).
Quantity in commerce: 12 units
Distribution: Worldwide Distribution - (USA) Nationwide Distribution
Product codes and lots: Lot numbers: 0006-1415; Catalog # 801764 System 1 Base, 220 V

Product code DTQ

K022947Class IIAdvanced Perfusion System 1 (100/120 Volt),advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 InchTerumo Cardiovascular Systems Corp. / cleared 2003-03-20

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)