Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 3, 2018
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not be…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Terumo Cardiovascular Systems Corporation recalled Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary b… - a moderate-severity action.
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary b… was recalled by Terumo Cardiovascular Systems Corporation in October 3, 2018. Reason: Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not t…. Check the official notice for the remedy. Verify recall #Z-3242-2018 with the FDA Devices before acting.
The recall
Terumo Cardiovascular Systems Corporation issued this moderate-severity FDA Devices recall-Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not t….
- Moderate
- severity level
- 47 units
- affected scope
- Class II
- classification
- October 3, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3242-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3242-2018) was formally reported on October 3, 2018, with the manufacturer initiating the action on August 28, 2018. 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 47 units.
The documented reason for this recall is: Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected du… Distribution data in the federal record shows the product reached: Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam. 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 - 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 - 40,422 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.
Affected scope
47 units
Related Recalls
6
0 from same agency
Product description
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
Reason for recall
Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3242-2018 |
| Date reported | October 3, 2018 |
| Date initiated | August 28, 2018 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Firm location | Ann Arbor, MI |
| Affected scope | 47 units |
| Distribution | Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam |
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-3242-2018) 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.
Frequently Asked Questions
What product was recalled? ▼
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 47 units.
Why was this product recalled? ▼
Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 3, 2018. Severity: Moderate. Recall number: Z-3242-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3242-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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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 October 3, 2018. 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.