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PRIMO2XRecalls & reported problems

Sorin Group Italia Srl · Class 2

Adverse event reports
1
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033178100687), received between Jan 10, 2018 and Jan 10, 2018 — classified as 1 death.

The most frequently reported specific device problem is “Low Readings” (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

  • Low Readings1

Patient problems

  • Abnormal Blood Gases1
  • Blood Loss1
  • Death1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • DeathJan 10, 2018Low Readings; Low Readings

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT A LOW PO2 VALUE WAS RECORDED FOR A PRIMO2X OXYGENATOR DURING A CIRCULATORY-ARREST CASE. THE USER REPORTEDLY CHECKED THE CONNECTIONS TO MAKE SURE GAS WAS FLOWING TO THE OXYGENATOR. THE FIO2 WAS TURNED UP AS THE PATIENT WAS COOLED TO 18°C AND THE PO2 DECLINED. AN O2 TANK WAS CONNECTED AS THE PATIENT WAS WARMED, BUT THEY WERE UNABLE TO REACH THE EXPECTED PO2 VALUE. THE OXYGENATOR WAS CHANGED OUT AND THE PATIENT WAS TAKEN OFF BYPASS. THE PATIENT EXPERIENCED SOME BLEEDING ISSUES AND REPORTEDLY EXPIRED ON (B)(6) 2017.

    Patient problems: Abnormal Blood Gases; Blood Loss; Death

    MAUDE report 7177927 ↗

Other OXYGENATOR, CARDIOPULMONARY BYPASS devices

All OXYGENATOR, CARDIOPULMONARY BYPASS devices →

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