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

FDA device recall Z-0299-2012 · posted 2011-11-29 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

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.

Action taken

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).

Root cause

Component design/selection

Status

Terminated

Product code

DTQ

Quantity affected

12 units

Distribution

Worldwide Distribution - (USA) Nationwide Distribution

Date initiated

2011-11-08

Date posted

2011-11-29

Date terminated

2012-08-22

Location

Ann Arbor, MI

Related 510(k) clearances