Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile… recallZ-1918-2018 · LivaNova USA · initiated Mar 13, 2018

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from LivaNova USA or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Incorrect or no expiration date

What the company is doing

On March 13, 2018, notification letters were emailed. Customers were instructed to return response forms, which indicated the following: amount of unused product, and whether they would contact the firm to relabel effected products or if they preferred to be trained on the relabeling procedure. If product was further distributed, customers were instructed to send the notification letter to these additional customers within 2 business days. No action is required for product already used since it was consumed prior to the true expiration date. For further questions, please call (281) 228-7260.

Recall details

Recall number: Z-1918-2018
Status: Terminated
Initiated by the company: Mar 13, 2018
Recalling firm: LivaNova USA
Quantity: 42
Product code: DTZ
FDA submissions: K130209
Distribution: US Distribution to the states of : NJ, CA, MN, MO, MA

Product description

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

Code information (models, lots, serial numbers)

Lot: 1709190228, UDI: (01)08033178112352(17)200917(10)1709190228, Exp: 09/17/2020

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

INSPIRE 6 PH.I.S.I.O.
Sorin Group Italia Srl · OXYGENATOR, CARDIOPULMONARY BYPASS
1 recall3 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 79863).

Z-1919-2018 · Terminated
Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices …

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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