Z-1450-2012

Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia Monitor The 8K Arterial Monitor is...

Name: Z-1450-2012 Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia Monitor The 8K Arterial Monitor is...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-03-21
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-03-21 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia Monitor The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion... on 2012-03-21. The reason FDA records is "Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could...". 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-1450-2012
Status: Terminated
Initiated: 2012-03-21
Posted: 2012-04-23
Terminated: 2013-07-11
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia Monitor The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could have been caused by soldering anomalies on the circuit board of the monitor. The compromised solder joints could cause intermittent or loss of display, or could cause monitor reset, po
Root cause tag: design
FDA root cause: Device Design
Action: TERUMO sent an URGENT MEDICAL DEVICE RECALL- SAFETY ADVISORY to all consignees on March 21, 2012 via Federal Express. Terumo issued the safety advisory to remind users how to intervene if they experienced intermittent or complete loss of pressure display on the arterial monitor or cartiplegia monitor, or a related pump stop. Customers were asked to review the Medical Device Correction notice, assure that all users are aware of the notice, confirm receipt of the communication by faxing the attached Customer Response Form to 1-800-292-6551. For questions regarding this recall call 1-800-521-2818.
Quantity in commerce: 3,022 units
Distribution: Worldwide Distribution - USA including AK, AL , AR, AZ , CA, CO , CT, DC, DE , FL, GA, HI, IA , ID , IL, IN , KS, KY , LA, MA , MD, MI, MN , MO, MS , MT, NC , ND, NE, NH, NJ, NM , NY, OH , OR, PA , RI, SC , TN, TX , VA, WA , WI, WV, WY, and Puerto Rico and the countries of PERU, Philippines, REPUBLICA, SANTIAGO, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tujunga, United Arab Emirates, Uruguay, Venezuela, Vietnam, Wooddale, and Yemen.
Product codes and lots: Catalog Number 16414; Lot/serial numbers: PT001*, 1001-1064, 1070-1146, 1148-1220,1222-1227,2000-2039,2045-2059,2061- 2064,2100-2157,2159-2203,2205-2335,2337-2399, 2401-2408,3000-3014,3016-3070,3072-3110,3112-3385, 3387-3558, and 3560-3840.

Product code DTQ

K915183Class IISarns 8000 Modular Perfusion System3M Health Care, Sarns / cleared 1992-07-08

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)