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MyCareLink Smart recallZ-0400-2018 · Medtronic Inc., Cardiac Rhythm and Heart Failure · initiated Jul 14, 2017

Terminated

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 Inc., Cardiac Rhythm and Heart Failure 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

Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports.

FDA root cause category: Error in labeling

What the company is doing

Customers were notified via letter on 07/14/2017. Medtronic communicated that an updated Clinician Instructions for Use has been released with the following updated information: In patients with more than one Medtronic implanted hear device, device data may not be able to transmit from any of the implanted devices to the physician via the Monitor; The patient could potentially transmit device data unintentionally from one of the implanted heart devices when attempting to transmit from another device implanted in the same patient; and a Medtronic Programmer can be used to obtain data from each implanted heart device. Instructions included to ensure all appropriate personnel are notified of this correction.

Recall details

Recall number
Z-0400-2018
Status
Terminated
Initiated by the company
Jul 14, 2017
Recalling firm
Medtronic Inc., Cardiac Rhythm and Heart Failure
Quantity
1,519,984 enrollments total
Product code
NVZ
FDA submissions
P890003
Distribution
Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Internationally: Austria, Belgium, Brunei, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lithuania, Malaysia, Malta, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom

Product description

MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device

Code information (models, lots, serial numbers)

Model 25000, UPN/GTIN 00643169527546, 00643169569744, 00643169666337, 00643169697843¿, 00643169862876, 00643169697850, 00643169742246, 00643169862883, 00643169666375, 00643169666382, 00643169666344, 00643169666351, 00643169666368, 00643169666320, 00643169590397, 00643169527584, 00643169527591, 00643169527553, 00643169527560, 00643169527577, 00643169947108

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

81 devices cleared under P890003 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 77964).

Sources and updates

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