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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61753

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 21, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Terumo Cardiovascular Systems Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

System 1 Base, 100/120V. The Terumo 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, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Z-2020-2012
Recall number
Z-2020-2012
Initiated
June 21, 2012
Classification
Class II
Status
Terminated
Quantity
992

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root cause. Potential risks with the loss or

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root cause. Potential risks with the loss or

Code information

Catalog Number: 801763 and Serial Numbers: 0011-0335,0337-0610,1001- 1034,1037-1049,1100,1103-1106,1109-1445, and 1447-1450.

Distribution pattern

Worldwide Distribution-USA (nationwide) 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, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV. and the countries of ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.

device · product 2 of 2

System 1 Base, 220/240V. The Terumo 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, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Z-2021-2012
Recall number
Z-2021-2012
Initiated
June 21, 2012
Classification
Class II
Status
Terminated
Quantity
648

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root cause. Potential risks with the loss or

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root cause. Potential risks with the loss or

Code information

Catalog Number: 801764 and Serial numbers: 0006-0066, 01 00-0311, 0313-0322,1001-1027,1100-1434,1436, 1440, and 1441.

Distribution pattern

Worldwide Distribution-USA (nationwide) 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, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV. and the countries of ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.