Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2014 - (Recall #: Z-2019-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)

Product Classification:

Class II

Date Initiated: June 17, 2014

Date Posted: July 16, 2014

Recall Number: Z-2019-2014

Event ID: 68244

Reason for Recall:

An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.

Status: Terminated

Product Quantity: 1713 units

Code Information:

Catalog Number 801764

Distribution Pattern:

Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of AUSTRALIA, BELGIUM, CANADA, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated