Events

Recall of Device Recall Terumo Perfusion System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    49604
  • Event Risk Class
    Class 2
  • Event Number
    Z-0295-2009
  • Event Initiated Date
    2008-05-23
  • Event Date Posted
    2008-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73901
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Heart Lung Console - Product Code DTQ
  • Reason
    The level sensor may not properly couple to the reservoir, resulting in a sensor "not attached" message, an alert or alarm condition, or a failure to detect a low level condition.
  • Action
    U.S. consignees were notified by (Urgent Medical Device Removal) letter dated 5/23/08 via FedEx and international affiliates were notified via e-mail on 5/27/08. Consignees were advised of the problem, and to continue using the affected sensors until replacements are available in late 2008. For questions or additional information, contact the Terumo CVS Customer Service at 1-800-521-2818.

Device

Device Recall Terumo Perfusion System
  • Model / Serial
    Serial Numbers: 2036, 3015 through 3086, 3090, 3092 through 3137, 1191x, 2012x through 2035x, 2037x through 2274x, 2276x through 2284x, 2287x through 2290x, 2292x, 2294x through 2297x, 2299x through 2302x, 2304x, 2306x through 2308x, 2311x through 2313x, 2315x through 2326x, 2328x, 2330x through 2337x, 2340x through 2341x, 2343x, 2346x, 2349x through 2352x, 2354x through 2356x, 2358x, 2360x, 2363x through 2365x, 2367x through 2375x, 2379x, 2381x through 2384x, 2391x, 2392x, 2394x, 2395x, 2398, 2399x, 2403x, 2404x, 2405x, 2407x, 2408x, 2410x, 2411x, 2413x, 2415x, 2416x, 2417x, 2419x, 2420x, 2421x, 2423x through 2427x, 2432x, 2435x through 2441x, 2443x through 2466x, 2468x through 2471x, 2473x through 2491x, 2497x through 2500x, 2502x, 2518x, 2521x, 2527x, 2529x through 2533x, 2548x and 2549x.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide including USA and countries of Australia, Belgium, Bolivia, Canada, Chile, Ecuador, Egypt, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Latin America, Malaysia, Panama, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Taiwan, Thailand, United Arab Emirates, Venezuela and Vietnam.
  • Product Description
    Terumo Sarns Level Sensor II (yellow) (Part # 195215) alert level sensor transducer for use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195215. Level sensors are distributed as a finished device, as part of a kit, with a perfusion system 8000 safety monitor or with an Advanced Perfusion System 1 base. || Level sensors are attached to the color coded connectors on the module and then to a hard-shell reservoir. Level detection is used to monitor blood levels in hard-shell reservoirs.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA