Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 1, 2017
The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected …
Terumo Cardiovascular Systems Corporation recalled The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The… - a moderate-severity action.
The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The… was recalled by Terumo Cardiovascular Systems Corporation in March 1, 2017. Reason: Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump …. Check the official notice for the remedy. Verify recall #Z-1235-2017 with the FDA Devices before acting.
The recall
Terumo Cardiovascular Systems Corporation issued this moderate-severity FDA Devices recall-Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump ….
- Moderate
- severity level
- 579 units
- affected scope
- Class II
- classification
- March 1, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1235-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1235-2017) was formally reported on March 1, 2017, with the manufacturer initiating the action on May 27, 2015. 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 Elkton, MD. Federal records list the affected scope as 579 units have entered into the distribution chain.
The documented reason for this recall is: Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and… Distribution data in the federal record shows the product reached: Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall. 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
579 units have entered into the distribution chain
Related Recalls
6
3 from same agency
Product description
The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
Reason for recall
Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and during CPB procedures. In each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks. Terumo Cardiovascular System's investigation into the incident has identified the cause of the leaks to be cracks in both the Top Housing and Magnet Back Housing of the pump. When the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1235-2017 |
| Date reported | March 1, 2017 |
| Date initiated | May 27, 2015 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Firm location | Elkton, MD |
| Affected scope | 579 units have entered into the distribution chain |
| Distribution | Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall |
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-1235-2017) 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? ▼
The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 579 units have entered into the distribution chain.
Why was this product recalled? ▼
Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and during CPB procedures. In each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks. Terumo Cardiovascular System's investigation into the incident has identified the cause of the leaks to be cracks in both the Top Housing and Magnet Back Housing of the pump. When the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 1, 2017. Severity: Moderate. Recall number: Z-1235-2017.
Where was the recalled product distributed? ▼
Distribution: Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1235-2017) 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 March 1, 2017. 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.