Terumo Cardioplegia Delivery Set recallZ-0158-2015 · Terumo Cardiovascular Systems Corp · initiated Mar 1, 2011
Class II Terminated All recalls posted in October 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terumo Cardiovascular Systems Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
FDA root cause category: Device Design
What the company is doing
Terumo Cardiovascualr notified accounts by letter dated 3/1/2011 advising users users that the luer connector to the table line in certain lots of myocardial protection sets may leak. Users should not continue to use affected myocardial protection sets in a manner that exposes the connector to negative pressure without taking correction or replacement activities as described. Firm provided mitigating instructions: Clamp the table line distal to the luer connector when ending an infusion of cardioplegia thus isolating the leak from negative pressure. Contact Terumo CVS Customer Service to report the defect and arrange return of the unit: 800-521-2818.
Recall details
- Recall number
- Z-0158-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 1, 2011
- Posted by the FDA
- Oct 31, 2014
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Quantity
- 777 units
- Product code
- DTR
- FDA submissions
- K823451
- Distribution
- Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
Product description
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
Code information (models, lots, serial numbers)
Lot Numbers: MN08, MNI5, MM11, MM18, MM25. Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0.
Other devices under the same FDA submission
1 device cleared under K823451 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Sarns™ Cardioplegia Set 16010Terumo Cardiovascular Systems Corporation · Heat-Exchanger, Cardiopulmonary Bypass1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 58185).
- Z-0156-2015 · TerminatedTerumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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