Medtronic Cobalt Implantable Cardioverter Defibrillators Recalled for Cathode Component Defect
Medtronic is recalling three Cobalt Implantable Cardioverter Defibrillators (CRT-D) due to a manufacturing error that may have resulted in a cathode component being out of specification. Affected patients should contact their physician.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II recall of a risk-of-harm implantable cardiac device with a manufacturing defect in a critical component. No injuries have been reported to date, but the cathode component being out of specification poses a potential safety risk in a life-sustaining device.
Plain-English summary
Medtronic Inc. is recalling three Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) due to a manufacturing error that may have resulted in a cathode component being out of specification.
The cathode component defect may affect the proper functioning of the device. However, all three recalled devices met final functional testing requirements.
The three affected units have serial numbers RTK601865S, RTK601825S, and RTK601828S. These units were distributed nationwide to Indiana and California.
Patients who have one of these devices should contact their physician or healthcare provider to discuss potential follow-up care or device options. Do not attempt to remove or adjust the device yourself.
The recalled product
- Product
- Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
- Affected units
- 3
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 (4)
- GTIN 00763000178178
- Serial Numbers: RTK601865S
- RTK601825S
- RTK601828S
Distribution
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