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NautilusTM ECMO Oxygenator with Balance Biosurface-used in… recallZ-1309-2024 · Mc3 Inc · initiated Oct 11, 2023

Open, Classified

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Mc3 Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer

FDA root cause category: Process control

What the company is doing

Medtronic (MC3's global distributor)issued issued Urgent Customer Notification letter to end-users on 11/26/24. Letter states reason for recall, health risk and action to take: " During the priming procedure, users may check water flow through the oxygenator water path prior to use. " Patient core body temperature must be monitored routinely during ECMO. Customer Actions: Medtronic records indicate that your facility has received at least one of the impacted serial numbers. As a result, Medtronic requests that you take the following actions: " Complete the enclosed Customer Confirmation Form, acknowledging that you have received this information, and email to [email protected] " This notice must be passed on to all who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Field Representative

Recall details

Recall number
Z-1309-2024
Status
Open, Classified
Initiated by the company
Oct 11, 2023
Posted by the FDA
Mar 19, 2024
Recalling firm
Mc3 Inc
Quantity
299 units
Product code
BYS
FDA submissions
K191935
Distribution
US Nationwide distribution.

Product description

NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E

Code information (models, lots, serial numbers)

GTIN: (1) 10854916006888; (2) 10854916006901,20854916006908 (New GTIN (USA only)After reboxing). All Serial Numbers between 481022923 and 481024039

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 94016).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page