Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 1, 2015
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. T…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Terumo Cardiovascular Systems Corp recalled Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the… - a moderate-severity action.
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the… was recalled by Terumo Cardiovascular Systems Corp in July 1, 2015. Reason: The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracopo…. Check the official notice for the remedy. Verify recall #Z-1828-2015 with the FDA Devices before acting.
The recall
Terumo Cardiovascular Systems Corp issued this moderate-severity FDA Devices recall-The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracopo….
- Moderate
- severity level
- 163 units
- affected scope
- Class II
- classification
- July 1, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1828-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1828-2015) was formally reported on July 1, 2015, with the manufacturer initiating the action on May 6, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Terumo Cardiovascular Systems Corp is listed as the recalling firm, operating out of Ashland, MA. Federal records list the affected scope as 163 devices.
The documented reason for this recall is: The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal … Distribution data in the federal record shows the product reached: Distributed to the states of MO and FL.. 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.
Medical Devices recalls over time
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.
Affected scope
163 devices
Related Recalls
6
3 from same agency
Product description
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Reason for recall
The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1828-2015 |
| Date reported | July 1, 2015 |
| Date initiated | May 6, 2015 |
| Recalling firm | Terumo Cardiovascular Systems Corp |
| Firm location | Ashland, MA |
| Affected scope | 163 devices |
| Distribution | Distributed to the states of MO and FL. |
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-1828-2015) 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? ▼
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.. Recalled by Terumo Cardiovascular Systems Corp. Units affected: 163 devices.
Why was this product recalled? ▼
The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2015. Severity: Moderate. Recall number: Z-1828-2015.
Where was the recalled product distributed? ▼
Distribution: Distributed to the states of MO and FL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1828-2015) 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 July 1, 2015. 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.