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Medtronic Carelink Monitor Model 2490C. The Medtronic… recallZ-2209-2010 · Medtronic Inc. Cardiac Rhythm Disease Managment · initiated Jun 11, 2010

Terminated All recalls posted in August 2010

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 Disease Managment 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

Medtronic has identified that a subset of 2490C CareLink Monitors recently received an incorrect software update. Patients reported that their monitor was making a "ticking sound" and they were unable to transmit device data via CareLink. These monitors are now non-functional. No patient injuries have been reported as a result of this issue.

FDA root cause category: Software change control

What the company is doing

Starting on 6/11/2010, Medtronic began sending Australian and Canadian consignees "Medical Device Recall" letters dated 6/10/2010. The letters describe the problem and product involved. The letters instructs consignees to order replacement monitors, notify affected patients, and instruct each patient to perform a manual transmission upon receipt of the new monitor. Medtronic will provide affected patients with a prepaid return kit to faciliate the return of the monitor to Medtronic. Australian consignees should contact Scott Dunlop at 61-7 3025-3547. Canadian consignees should contact Medtronic Patient Services at 1-800-268-5346.

Recall details

Recall number
Z-2209-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 11, 2010
Posted by the FDA
Aug 11, 2010
Recalling firm
Medtronic Inc. Cardiac Rhythm Disease Managment
Quantity
37 Foreign, 0 Domestic
Product code
NVZ
FDA submissions
P890003
Distribution
International Distribution Only: Australia and Canada.

Product description

Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic wireless communication between the heart device and the monitor takes place at times scheduled by the doctor or clinic. The gathered heart device information is sent over a telephone line to the clinic using a toll-free number. The monitor can also send wireless heart device alerts to the clinic automatically.

Code information (models, lots, serial numbers)

Lot Serial No IJX061043P IJX061063P IJX067150P IJX067158P IJX067162P IJX013664P IJX013831P IJX014701P IJX014899P IJX015305P IJX015406P IJX015768P IJX062594P IJX062607P IJX062654P IJX062655P IJX062656P IJX062661P IJX062669P IJX062670P IJX062672P IJX062673P IJX062674P IJX062683P IJX062698P IJX062701P IJX062706P IJX062716P IJX062727P IJX062734P IJX062736P IJX062738P IJX062739P IJX062741P IJX062747P IJX062763P IJX062764P

Other devices under the same FDA submission

83 devices cleared under P890003 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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