Device recall: Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product…

Class II FDA enforcement event 58185. Recall start date: 1 Mar 2011. Status in the FDA record: Terminated. Termination date: 6 Nov 2014.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Terumo Cardiovascular Systems Corp started this device recall on 1 Mar 2011. The firm address in the FDA record is in Ashland, MA. FDA put the recall in Class II. FDA event 58185 has 6 product records. The first FDA enforcement report date is 12 Nov 2014. The record gives the status Terminated, with the termination date 6 Nov 2014.

FDA enforcement report The 6 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.

Recalling firm

Terumo Cardiovascular Systems Corp, Ashland, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

6 product records in the event.

FDA event 58185: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0156-2015	Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1…	596 units; 876 units	Class II	Terminated	12 Nov 2014
Z-0157-2015	Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity	165 units	Class II	Terminated	12 Nov 2014
Z-0158-2015	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.	777 units	Class II	Terminated	12 Nov 2014
Z-0159-2015	Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardioplegia Delivery Sets are indicated for delivery of…	Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 units	Class II	Terminated	12 Nov 2014
Z-0160-2015	Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer…	Catalog: 16579 ; Catalog 6375: 3256 units	Class II	Terminated	12 Nov 2014
Z-0161-2015	Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity	24 units	Class II	Terminated	12 Nov 2014

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2011: 114
Share of these events in Class II: 89%
Product records in this event: 6Median of the firm: 1
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of Terumo Cardiovascular Systems Corp
Initiated	Product (first record)	Type	Class	Records
3 Feb 2022	Cardiovascular Procedure Kit catalog # 76645 & 73806	Device	Class II	1
18 Dec 2017	Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters. The Ca	Device	Class II	1
12 May 2017	Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of th	Device	Class II	1
25 Jul 2016	Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This prod	Device	Class II	1
24 Aug 2015	Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufacture	Device	Class II	7
6 May 2015	Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the ca	Device	Class II	1
28 Mar 2014	Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431	Device	Class II	1

Terumo Cardiovascular Systems Corp: all 8 events

Official channels

FDA enforcement report Z-0156-2015The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 58185. https://recallregister.com/fda/ii/58185/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
What quantity of product is in FDA event 58185?: The event has 6 product records. The first record gives this quantity: 596 units; 876 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2011 have the same class?: 89% of the 114 device events that started in 2011 are in Class II.