Z-1005-2007

Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distributed within the...

Name: Z-1005-2007 Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distributed within the...
Creator: Terumo Cardiovascular Systems Corp
Published: 2004-07-01
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2004-07-01 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distributed within the United States) on 2004-07-01. The reason FDA records is "Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1005-2007
Status: Terminated
Initiated: 2004-07-01
Posted: 2007-07-07
Terminated: 2007-12-12
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distributed within the United States).
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.
FDA root cause: Other
Action: As the complaints were received (between 07/04 and 01/06), the firm visited the customer filing the complaint and repaired the pumps demonstrating the problem. The firm will correct other units as complaints are received. The firm modified its recall strategy and issued a Device Correction Letter dated 6/22/07 notifying all users of the problem
Quantity in commerce: 728 pumps of all models
Distribution: Worldwide: USA and Bangladesh, Belgium, Bolivia, Canada, Chile, Colombia, Costa Rica, Egypt, Equador, Hong Kong, India, Indonesia, Japan, Latin America, Malaysia, Nicaragua, Philippines, Saudi Arabia, Taipe, Taiwan, United Arab Emirates, Uruguay, and Viet Nam.
Product codes and lots: Serial numbers 10031, 10033, 10137, 10138, 10614, 10663, 10730, 11131, 11281, 11283, 11361, 11548, 11630, 11751, 12110, 12604, 12686, 12938, 13129, 13719, 13826, 13830, 14712, 15090, 15277, 15278, 15279, 15280, 15284, 15285, 15304, 16003, 16087, 16190, 17099, 17345, 17432 and 17437 through 18122 may be affected by the problem. None have been corrected.

Product code DTQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)