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Hemocor HPH HPH 400Recalls & reported problems

Medivators Inc. · High Performance Hemoconcentrator · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00677964011207), received between Sep 7, 2018 and Jun 8, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak1
  • Fracture1

Patient problems

  • Blood Loss1
  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A HPH-1000 HEMOCONCENTRATOR, THE CUSTOMER NOTICED A LEAK AT THE TOP OF THE DEVICE. THE PERFUSIONIST WAS ABLE TO FINISH THE CASE AND THE PATIENT WAS FINE, BECAUSE THEY WERE ABLE TO CONTINUE ULTRAFILTRATION THE ANESTHESIOLOGIST MANAGED K+ LEVELS WITH INSULIN. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: THERE WAS NO BLOOD LOSS REPORTED AND A BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT DID NOT HAVE ANY REPORTED UNDERLYING KIDNEY CONDITION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11956854 ↗
  • InjurySep 7, 2018Fracture; Fracture

    (B)(4), DISTRIBUTOR OF HEMOCOR HEMOCONCENTRATORS, REPORTED ON BEHALF OF A USER FACILITY THAT WHILE USING A MEDIVATORS HPH 400 HEMOCONCENTRATOR, A PEDIATRIC PATIENT LOST ABOUT 100 ML OF BLOOD. THERE WAS NO EFFECT ON THE PATIENT.

    Patient problems: Blood Loss; No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 7857354 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.