Crome Implantable Cardioverter Defibrillators Recalled for Reduced Shock Energy
Medtronic is recalling 1,657 Crome implantable cardioverter defibrillators due to potential reduced shock energy during high-voltage therapy. Affected devices may deliver only 79% of programmed energy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity of 4. The device is a life-critical cardiac therapy system where failure to deliver adequate shock energy could prevent life-saving treatment. Although no illnesses or deaths have been reported to date, the potential for device malfunction during critical therapy warrants severe classification.
Plain-English summary
Medtronic Inc. is recalling specific models of Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The devices may deliver reduced shock energy—approximately 79% of the programmed energy—during high-voltage therapy delivery. This reduction in shock energy could impair the effectiveness of life-saving defibrillation therapy.
The recall affects 1,657 devices with specific serial numbers distributed worldwide. The affected models are the Crome VR ICD (Model Numbers DVPC3D1, DVPC3D4) and Crome DR ICD (Model Numbers DDPC3D1, DDPC3D4). Patients with these devices should verify their device serial number against the recall notice.
If you have one of these devices, contact your healthcare provider or Medtronic immediately to discuss whether your device requires assessment or replacement. Do not discontinue use of your device without medical guidance, as it continues to provide protection despite this potential issue.
The recalled product
- Product
- Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-shock-energy
- defibrillation-failure
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. Model Numbers: DVPC3D1: GTIN 00763000178543
- Serial Numbers: RSG600007S
- RSG600008S
- RSG600009S
- RSG600010S
- RSG600011S
- RSG600012S
- RSG600013S
- RSG600014S
- RSG600017S
- RSG600018S
- RSG600020S
- RSG600022S
- RSG600023S
- RSG600024S
- RSG600025S
- RSG600026S
- RSG600027S
- RSG600028S
- RSG600029S
Distribution
Distribution scope not specified by the agency.
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