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Recall Observatory FDA recall evidence

Device product

MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.

Z-2735-2015

August 18, 2015

Class II

Product summary

Firm
Medtronic Perfusion Systems
Event
Event 72025
Status
Terminated
Classification
Class II
Quantity
1594 total (1306 US, 288 OUS)
Official record key
device-enforcement:Z-2735-2015

Official wording

Reason: Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs.

Code information: 759625A 759884A 759491A 762355A

Distribution pattern: Worldwide Distribution-US (nationwide) including the states of AL, AR, CA, CO, FL, HI, ID, IN, KS, LA, MA, MS, MO, NY, NJ, OH, PA, TN, TX, UT, and WI, and the countries of Bolivia, Denmark, Dominican Republic, Italy, Latvia, Lebanon, Mexico, Panama, Singapore, Venezuela, and Zambia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs.