FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
- Recall number
- Z-2177-2012
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
- Status
- Terminated
- Initiated
- 2012-07-26
- Posted
- 2012-08-09
- Terminated
- 2012-11-16
- Reason
- Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS re
- Root cause
- Component design/selection
- Action
- The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" letter dated July 26, 2012 to its customers. The letter described the product, problem and actions to be taken. To customers were instructed to review this Medical Device Recall notice and addendum; assure that all users are aware of this notice and addendum; place the addendum in the front of Section 7: Modules (p 7.1) and confirm receipt of this communication by faxing the attached Customer Response Form to the fax number/email address indicated on form. Terumo CVS is issuing a Safety Advisory to alert all Terumo System 1 users of the potential for failure and providing an addendum for the Operator Manual with instruction on how to respond to the failure. If you have any question or concerns contact Terumo CVS Customer Service at 1-800-521-2818. Customer Service hours are Monday-Friday, 8AM - 6PM ET.
- Quantity
- 992 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Japan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
- Lot, serial or model codes
- catalog number: 801763 and serial numbers: 0011-0335, 0337-0610,1001-1034, 1037-1049,1100,1103-1106,1109-1450, and 1452.
- 510(k) numbers
- ["K022947"]
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28