Severity
Moderate
FDA Devices recall · Reported August 21, 2013
Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor move…
Terumo Cardiovascular Systems Corporation recalled Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product… - a moderate-severity action.
Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product… was recalled by Terumo Cardiovascular Systems Corporation in August 21, 2013. Reason: Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal…. Check the official notice for the remedy. Verify recall #Z-1974-2013 with the FDA Devices before acting.
The recall
Terumo Cardiovascular Systems Corporation issued this moderate-severity FDA Devices recall-Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1974-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1974-2013) was formally reported on August 21, 2013, with the manufacturer initiating the action on July 26, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Terumo Cardiovascular Systems Corporation is listed as the recalling firm, operating out of Ann Arbor, MI. Federal records list the affected scope as 1657.
The documented reason for this recall is: Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will i… Distribution data in the federal record shows the product reached: Worlwide Distribution - US Nationwide: AL,AR,AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
1657
Related Recalls
6
3 from same agency
Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: 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 TM or similar equipment.
Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement (as it is designed) and display a Service Pump message error. The user might interpret this as a pump which requires service rather than a message displayed due to pump movement while not activated.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1974-2013 |
| Date reported | August 21, 2013 |
| Date initiated | July 26, 2013 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Firm location | Ann Arbor, MI |
| Affected scope | 1657 |
| Distribution | Worlwide Distribution - US Nationwide: AL,AR,AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of: AU… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 21, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.