CLASS II Device recall · Reported 16 Sep 2015 · FDA Enforcement Report

Medivators Hemocor Hph700, Hph-1400ts, Hph-1000ts recalled

Medtronic Perfusion Systems is recalling Medivators Hemocor Hph700, Hph-1400ts, Hph-1000ts, distributed nationwide in the US. The recall was initiated on 18 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes759625A 759884A 759491A 762355A

Quantity recalled1594 total (1306 US, 288 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2735-2015
FDA event ID: 72025
Recalling firm: Medtronic Perfusion Systems, Brooklyn Park, MN
Classification: Class II
Status: Terminated
Recall initiated: 18 Aug 2015
FDA classified: 4 Sep 2015
Reported: 16 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

18 Aug 2015	Recall initiated by company
4 Sep 2015	Classified by FDA	+17 days
16 Sep 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alabama Arkansas California Colorado Florida Hawaii Idaho Indiana Kansas Louisiana Massachusetts Missouri Mississippi New Jersey New York Ohio Pennsylvania Tennessee Texas Utah

Questions about this recall

Why was it recalled?

Which lots are affected?

759625A 759884A 759491A 762355A

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 72025

This product is part of a recall event; the main page for the event is Medtronic Perfusion Tubing Packs recalled.

Reported	Class	Recall	Company	Reason	Where
16 Sep 2015	CLASS II	Medtronic Perfusion Tubing Packs recalled	Medtronic Perfusion Systems	Other	Nationwide

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