MyCareLink Patient Monitors. It is intended for used recall
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic…
Why was MyCareLink Patient Monitors. It is intended for used 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model (UPN/GTIN): 24950 (00643169292284, 00643169292345, 00643169292260, 00643169292529, 00643169292208, 00643169292192, 00643169292222, 00643169292239, 00643169292321, 00643169292215, 00643169292246, 00643169409132, 00643169292253, 00643169292277, 00643169292291, 00643169292307, 00643169292314, 00643169292338); 24950D (643169467163, 00643169441484, 00643169441101, 00643169367173, 00643169367227, 00643169367159, 00643169409156, 00643169367296, 00643169367302, 00643169367258, 00643169367180, 00643169367166, 00643169367210, 00643169367289, 00643169409149, 00643169367197, 00643169367142, 00643169367241, 00643169367203); 24950D1 (00643169486744); 24950E (00643169493667, 00643169493681, 00643169493698, 00643169493674, 00643169451988, 00643169452015, 00643169452107, 00643169452039, 00643169452121, 00643169452008, 00643169452145, 00643169452046, 00643169452022, 00643169452053, 00643169452138, 00643169452060, 00643169451995, 00643169452114, 00643169452152, 00643169452077, 00643169452084, 00643169452091); 24950F (00643169545274, 00643169552074); 24950G (00643169663039 00643169624337, 00643169599987, 00643169599994, 00643169624368, 00643169624351, 00643169624344, 00643169552104); 24950GLQ (00643169552289, 00643169552050, 00643169552067); 24950J (00643169840591, 00643169658011, 00643169658066, 00643169657892, 00643169658073, 00643169786196, 00643169658059, 00643169658028, 00643169658004, 00643169657908, 00643169657915, 00643169657946, 00643169657953, 00643169657960, 00643169657977, 00643169657984, 00643169657991, 00643169657922, 00643169657939, 00643169658042, 00643169658080, 00643169658097, 00643169657885, 00643169705746, 00643169658035); 24950JLQ (00643169658127, 00643169658134, 00643169658141, 00643169947115, 00643169705753); 24950K (00643169725270, 00643169725324, 00643169725201, 00643169725355, 00643169725331, 00643169725317, 00643169725287, 00643169725263, 00643169725294, 00643169725218, 00643169725232, 00643169725249, 00643169725256, 00643169725225, 00643169725300, 00643169725348, 00643169725195); 24950KLQ (00643169725362, 00643169725379, 00643169725386)
- Product
- MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic…
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure
- Quantity
- 1,519,984 enrollments total
- 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
- Recall date
- January 31, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)