Medtronic Cobalt ICD and CRT-D Telemetry Software Error Recall
Medtronic is recalling Cobalt and Crome ICDs and CRT-Ds due to a software telemetry error in the CareLink SmartSync Device Manager. The error may affect device communication and remote monitoring.
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 an FDA Class II recall affecting implantable cardiac devices where a telemetry error could impact critical device-to-clinician communication and remote monitoring functions. No reported injuries, illnesses, or deaths have been documented, which places this as a risk-of-harm product without yet-reported injury per the rubric.
Plain-English summary
Medtronic Inc. is recalling approximately 51,922 units of certain Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) loaded with CareLink SmartSync Device Manager application software. Multiple Cobalt models are affected, including Cobalt XT VR, Cobalt VR, Cobalt XT DR, Cobalt DR, Cobalt XT HF, Cobalt HF, and related Quad variants. The devices were distributed nationwide across all U.S. states and territories, as well as internationally to multiple countries.
A telemetry error may occur in the affected devices that could disrupt communication between the implanted device and external monitoring systems. This error could potentially impact remote patient monitoring and device-to-clinician communication. No illnesses, injuries, or deaths have been reported in connection with this issue.
Patients with an implanted device should contact their healthcare provider or Medtronic to determine whether their device is affected by this recall. Patients should continue using their devices as prescribed and should not discontinue device use without consulting their physician. Healthcare providers can verify affected devices by checking serial numbers against the FDA's official recall documentation.
The recalled product
- Product
- Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt…
- Affected units
- 51,922
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 (20)
- a) Cobalt XT VR: DVPA2D1
- DVPA2D4: Model DVPA2D1: GTIN 00763000178451
- Serial Numbers: RSC600175S
- RSC600169S
- RSC600211S
- RSC600163S
- RSC600177S
- RSC600212S
- RSC600237S
- RSC600217S
- RSC601072S
- RSC601241S
- RSC601396S
- RSC600327S
- RSC600018S
- RSC600347S
- RSC600391S
- RSC600419S
- RSC601490S
- RSC600423S
Distribution
Part of a larger recall action
This product is one of 2 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
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- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
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- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
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Same hazard · telemetry error
See all →- HighMedtronic Crome and Cobalt Cardiac Defibrillators Recalled Due to Telemetry Error
FDA (Devices) · 2022-06-22
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