Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Inspire 6 Integrated Phisio OXY w/ HVR Reservoir Recalled by LivaNova USA Due to Some integrated sterile INSPIRE family products contain an...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LivaNova USA directly.
Affected Products
Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 6M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, de-foams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. The INSPIRE HVR is intended to be used for 6 hours or less
Quantity: 42
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 5 states: CA, MA, MN, MO, NJ
About LivaNova USA
LivaNova USA has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report