MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	INSPIRE 6F STERILE
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 to a5: patient information was not provided.H11: livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Sorin group italia received a report of a poor gas exchange performance related to two units of inspire 6f oxygenator.There was no report of any patient injury.
Additional Manufacturer Narrative
H11: through follow-up communications, livanova learned that the events of poor gas exchange and consequent change out of the devices occurred in the still heart-beating phase, thus before aortic cross-clamp was applied to the patient.Based on above, the event was re-assessed as not reportable, since it is not likely to result in patient injury or death, even if it recurs.
Event or Problem Description
See initial report.

• Brand Name: INSPIRE OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 24401203
• Report Number: 9680841-2026-900008
• Device Sequence Number: 8158927
• Product Code: DTZ
• UDI-Device Identifier: 08033178112376
• UDI-Public: (01)08033178112376(17)260130(10)2301310077(11)230131(240)050715
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K201916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2026
• Device Model Number: INSPIRE 6F STERILE
• Device Catalogue Number: 050715
• Device Lot Number: 2301310077
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 06/12/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/01/2026; 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown