INSPIRE 6 PH.I.S.I.O.Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033178112352), received between Jan 29, 2019 and Dec 18, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 13, 2018Terminated

   Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed.

   Z-1918-2018 · Root cause: Incorrect or no expiration date · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  SEE INITIAL REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23836168 ↗
• MalfunctionFeb 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  SORIN GROUP ITALIA HAS RECEIVED A REPORT OF A LEAKAGE FROM THE TEMPERATURE PROBE OF ANY INSPIRE 6 OXYGENATOR. MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR TO COMPLETE THE CASE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16323464 ↗
• MalfunctionJan 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT AT THE BEGINNING OF THE CARDIOPULMONARY BYPASS, A LEAK NOTICED FROM THE ARTERIAL TEMPERATURE PROBE WELL OF THE INSPIRE 6 OXYGENATOR ACCORDING TO INFORMATION, NO LEAK WAS DETECTED DURING PRIMING. TOTAL BLOOD LOSS WAS APPROXIMATELY 20CC. LIVANOVA WAS INFORMED BY US MAIL ON 12/31/2018 THE CASE WAS REPORTED: REPORT MEDWATCH # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8284773 ↗