Medtronic Perfusion Systems: Medical Device Recall in 2015 - (Recall #: Z-2735-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 18, 2015

Date Posted: September 16, 2015

Recall Number: Z-2735-2015

Event ID: 72025

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1594 total (1306 US, 288 OUS)

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.

Voluntary or Mandated:

Voluntary: Firm initiated