Medtronic Cobalt DR MRI SureScan Defibrillators Recalled for Potential Loss of Function
Medtronic is recalling two specific MRI SureScan defibrillators because a component failure could cause the device to lose function.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a failure could lead to loss of function, but the source text does not report any specific injuries, hospitalizations, or deaths, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic Inc. is recalling two units of the Cobalt DR MRI SureScan DDPB3D1, an MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry. The recall affects specific serial numbers RSN600251S and RSN600656S.
The recall is being issued because, under rare circumstances, a component in the device may be susceptible to a failure mechanism. This failure could impact overall device performance, including the potential loss of function.
The affected units were distributed to the US states of Georgia, Pennsylvania, and New Jersey, as well as France. Patients with these specific devices should contact their healthcare provider or Medtronic for further instructions regarding the recall.
The recalled product
- Product
- Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial Numbers: RSN600251S
- RSN600656S
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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