Z-1111-2020Class II

Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 -

Name: Z-1111-2020 Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 -
Creator: Terumo Cardiovascular Systems Corporation
Published: 2020-01-10
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2020-01-10 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal... on 2020-01-10. FDA classified it as Class II and gives the reason as "These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1111-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-10
Posted: 2020-02-07
Terminated: 2020-05-12
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Terumo began notifying customers via telephone to schedule the repairs on 1/2/20. Urgent Medical Device Correction notification letters dated 1/6/20 were sent to customers.
Quantity in commerce: 11
Distribution: Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan.
Product codes and lots: Serial Numbers: 880559 880560 882808 882809 882810 882811 882812 882813 885541 885542 885543

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1111-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1108-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-07
Z-1109-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-07
Z-1110-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-07
Z-1111-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-07

Product code DTQ

K172220Class IIAdvanced Perfusion System 1Terumo Cardiovascular Systems Corporation / cleared 2017-08-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)