FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
- Recall number
- Z-1321-2012
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
- Status
- Terminated
- Initiated
- 2012-03-16
- Posted
- 2012-03-27
- Terminated
- 2013-05-02
- Reason
- Terumo CVS has received reports of 27 instances in which the 6 inch Roller Pump jammed during cardioplegia delivery. There has been one report of the pump jamming during a case that concluded with an adverse patient outcome, although there was no indication that the pump jam contributed to the adverse patient outcome.
- Root cause
- Device Design
- Action
- "URGENT MEDICAL DEVICE RECALL" letters were sent on 3/16/12 to all consignees detailing the correction as well as also adding an Addendum to the Operator's manual for the Terumo System 1 to incorporate additional information and warnings for use when operating a 6" roller pump with dual-sized tubing. For questions call 1-800-521-2818.
- Quantity
- 648 units
- Distribution
- Worldwide Distribution--USA, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, Puerto Rico and the countries of INDIA, CANADA, CHILE, HONG KONG, EGYPT, PAKISTAN, KUWAIT, SAUDI ARABIA, JORDAN, UNITED ARAB EMIRATES, SOUTH AFRICA, SOUTH KOREA, PHILIPPINES, JAPAN, PHILIPPINES, SINGAPORE, AUSTRALIA, MALAYSIA, TAIWAN, RUSSIA, TURKEY, BELGIUM, GERMANY, COLUMBIA, COSTA RICA, ARGENTINA, HONDURAS, COLUMBIA, DOMINICAN REPUBLIC, GUATEMALA, MEXICO, VIETNAM, and THAILAND.
- Lot, serial or model codes
- Lot numbers: 0006-0066, 0100-0322, 1001-1027, 1100-1434, and 1436.
- 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