Perfusion Pack (UDI 00803622150098)Recalls & reported problems
- 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 00803622150098), received between Jun 12, 2026 and Jun 12, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Unexpected Therapeutic Results” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Unexpected Therapeutic Results2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2026Unexpected Therapeutic Results
SORIN GROUP ITALIA RECEIVED A REPORT OF INSPIRE 8F OXYGENATOR PERFORMANCE PROBLEMS, UPON INITIATION OF BY-PASS. IN DETAILS, VALUES OF PARTIAL PRESSURE OF OXYGEN (PO2) WAS 47 MMHG WITH FI02 OF 100% AND GAS SWEEP OF 2.5L/MIN. A SECOND OXYGENATOR WAS PLACED IN TANDEM WITH THE INVOLVED ONE WITHOUT THE NEED TO REMOVE THE PATIENT FROM BY-PASS. ANESTHETIST SUPPORTED THE PATIENT WITH ADDITIONAL FI02 AND VENTILATION SUPPORT. AFTER THE SECOND OXYGENATOR WAS PLACED, PATIENT P02 WAS MEASURED AND IT WAS 583 MMHG. THERE WAS NO PATIENT INJURY. BASED ON MEDICAL ASSESSMENT, THE USE OF TWO OXYGENATORS IN TANDEM HAS BEEN CONSIDERED AN ADDITIONAL INTERVENTION TO PRECLUDE SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25481877 ↗InjuryJun 12, 2026Unexpected Therapeutic Results
SORIN GROUP ITALIA RECEIVED A REPORT OF INSPIRE 8F OXYGENATOR PERFORMANCE PROBLEMS, UPON INITIATION OF BY-PASS. IN DETAILS, VALUES OF PARTIAL PRESSURE OF OXYGEN (PO2) WAS 47 MMHG WITH FI02 OF 100% AND GAS SWEEP OF 2.5L/MIN. A SECOND OXYGENATOR WAS PLACED IN TANDEM WITH THE INVOLVED ONE WITHOUT THE NEED TO REMOVE THE PATIENT FROM BY-PASS. ANESTHETIST SUPPORTED THE PATIENT WITH ADDITIONAL FI02 AND VENTILATION SUPPORT. AFTER THE SECOND OXYGENATOR WAS PLACED, PATIENT P02 WAS MEASURED AND IT WAS 583 MMHG. THERE WAS NO PATIENT INJURY. BASED ON MEDICAL ASSESSMENT, THE USE OF TWO OXYGENATORS IN TANDEM HAS BEEN CONSIDERED AN ADDITIONAL INTERVENTION TO PRECLUDE SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25481870 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.