Medtronic Crome and Cobalt Cardiac Defibrillators Recalled Due to Telemetry Error
Medtronic recalls 3,944 Crome and Cobalt ICDs and CRT-Ds due to a potential telemetry error affecting device communication with external monitors.
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 of implantable cardiac devices (ICDs and CRT-Ds), which are inherently risk-of-harm products used for life-critical cardiac functions. Although no illnesses or injuries have been reported and the telemetry error is theoretical, the potential to impair remote monitoring of these life-critical devices justifies a High severity rating.
Plain-English summary
Medtronic Inc. is recalling certain Crome and Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) loaded with CareLink SmartSync Device Manager application software D00U005. The recall affects 3,944 units across multiple models including Crome VR (DVPC3D1, DVPC3D4), Crome DR (DDPC3D1, DDPC3D4), Crome HF (DTPC2D4, DTPC2D1), and Crome HF Quad (DTPC2QQ, DTPC2Q1).
The recall is issued because of a telemetry error that may occur in these devices. Telemetry errors could affect the device's ability to communicate with external monitors and systems, potentially impairing remote monitoring and preventing proper adjustments to device settings.
The affected devices were distributed nationwide to all U.S. states and to multiple countries internationally, including Canada, Australia, Japan, the United Kingdom, and others. Patients with these specific device models should verify whether their device is affected by contacting their healthcare provider.
Patients who believe they may have an affected device should contact their healthcare provider immediately for verification using their device serial number. Healthcare providers should consult FDA recall information and Medtronic's guidance for appropriate patient management.
The recalled product
- Product
- Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q1
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- telemetry-error
- communication-error
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) Crome VR: DVPC3D1
- DVPC3D4
- Model DVPC3D1: GTIN 00763000178536
- Serial Numbers: RSG600215S
- RSG600212S
- RSG600196S
- RSG600280S
- RSG600223S
- RSG600208S
- RSG600106S
- RSG600094S
- RSG600125S
- RSG600193S
- RSG600006S
- RSG600123S
- RSG600016S
- RSG600136S
- RSG600249S
- RSG600113S
- RSG600395S
Distribution
Distributed nationwide across the United States.
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