Z-1337-2019Class II

Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The...

Name: Z-1337-2019 Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2019-04-18
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2019-04-18 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and... on 2019-04-18. FDA classified it as Class II and gives the reason as "The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter". 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-1337-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-18
Posted: 2019-05-15
Terminated: 2020-05-20
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Terumo, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 18, 2019 to its customers. The letter described the product, problem and actions to be taken. The Customers were instructed to take the following actions: 1. Review this Medical Device Recall notice. 2. Assure that all users have received notice of this issue, and prominently display this notice where all users may access it. 3. Continue use of the device in conjunction with the backup external mechanical flowmeter found in the Terumo System 1 Accessory Kit. 4. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. 5. Terumo CVS will contact users to schedule the field correction activities. Note: Terumo CVS recommends that users continue using their Terumo System 1 with EGPS, with the required backup external mechanical flowmeter, while waiting for this correction. Customers with questions are directed to the following: Terumo CVS Customer Service: 1.800.521.2818 Monday - Friday 8 a.m. to 6 p.m. ET Recall Fax: 1.734.741.6149
Quantity in commerce: 1258
Distribution: Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and United Arab Emirates.
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1337-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1337-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-15

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)