FDA Devices recall · Reported August 21, 2013
Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 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.
The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the…
Terumo Cardiovascular Systems Corporation recalled Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Teru… - a moderate-severity action.
Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Teru… was recalled by Terumo Cardiovascular Systems Corporation in August 21, 2013. Reason: The operators manual does not fully describe the sequence of expected events that will occur when a specific …. Check the official notice for the remedy. Verify recall #Z-1968-2013 with the FDA Devices before acting.
The recall
Terumo Cardiovascular Systems Corporation issued this moderate-severity FDA Devices recall-The operators manual does not fully describe the sequence of expected events that will occur when a specific ….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- August 21, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1968-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 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.
Reason for recall
The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1968-2013 |
| 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 | Worldwide Distribution - USA (nationwide) including the countries of Australia, Dubai, Hong Kong, Indonesia, Singapore, China, Mexico, British Columbia, Taiwan, Thailand, Chile, Malaysia, Japan, Belgium, United Arab Emirates (UAE), South K… |
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.
- Check the recall number (Z-1968-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026