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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 1,657
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.
Part of a larger recall action
This product is one of 6 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 6 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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Same hazard · reduced shock energy
See all →- SevereCobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy
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- SevereMedtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect
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- SevereCobalt Implantable Cardioverter Defibrillators May Deliver Reduced Shock Energy
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- SevereCobalt Implantable Defibrillators May Deliver Reduced Shock Energy
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