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.
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: 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 H
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- telemetry-error
- software-defect
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
Distributed nationwide across the United States.
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