Z-0158-2015Class II

Terumo Cardioplegia Delivery Set- Item Number: 16130

Name: Z-0158-2015 Terumo Cardioplegia Delivery Set- Item Number: 16130
Creator: Terumo Cardiovascular Systems Corp
Published: 2011-03-01
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-03-01 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the... on 2011-03-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0158-2015
Classification: Class II
Status: Terminated
Initiated: 2011-03-01
Posted: 2014-10-31
Terminated: 2014-11-06
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: 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.
Product code: DTR Heat-Exchanger, Cardiopulmonary Bypass
Reason for recall: 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
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 777 units
Distribution: Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
Product codes and lots: Lot Numbers: MN08, MNI5, MM11, MM18, MM25. Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0158-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0156-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-10-31
Z-0157-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-10-31
Z-0158-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-10-31
Z-0159-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-10-31
Z-0160-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-10-31
Z-0161-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-10-31

Product code DTR

K823451Class IIClear Cardioplejia Delivery System3M Health Care, Sarns / cleared 1983-01-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)