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Duet recallZ-2412-2023 · Medtronic Neurosurgery · initiated Jun 28, 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 Medtronic Neurosurgery 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

Product labeling contains incorrect expiration date

FDA root cause category: Labeling Change Control

What the company is doing

On June 28, 2023, Medtronic Neurosurgery issued a "Urgent: Medical Device Recall" Notification to affected consignees via FedEx and email. Medtronic asked consignees to take the following actions: 1. Immediately identify and quarantine unused affected products within your inventory. 2. Return the affected product per the return instructions listed in the Customer Confirmation Form. 3. Complete and return the Customer Confirmation Form, even if you do not have any affected product. 4. Share this recall notification with all who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. 5. Medtronic is communicating this information to the appropriate regulatory agencies. Adverse events or quality problems experienced with this product should be reported to Medtronic and to the FDA MedWatch Adverse Event Reporting program via: " Contact Medtronic Customer Quality at [email protected] " Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm " FDA telephone at 1-800-FDA-1088 (1-800-332-1088)

Recall details

Recall number
Z-2412-2023
Status
Open, Classified
Initiated by the company
Jun 28, 2023
Posted by the FDA
Aug 17, 2023
Recalling firm
Medtronic Neurosurgery
Quantity
44 units
Product code
JXG
FDA submissions
K984053
Distribution
US Nationwide distribution in the states of NJ, FL, CA, IL.

Product description

Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only

Code information (models, lots, serial numbers)

Lot # 226632942; UDI-DI: 00763000624781

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

33 devices cleared under K984053 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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