Implantable Heart Defibrillators May Fail to Deliver Therapy
Medtronic implantable heart defibrillators may fail to deliver therapy during emergencies. The rare defect affects 510 devices distributed nationwide and worldwide.
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 per the severity rubric must receive a severity score of at least 4 (Severe). Although no deaths or injuries have been reported, the potential for therapy delivery failure in a critical cardiac device represents a serious health hazard.
Plain-English summary
Medtronic Inc., Cardiac Rhythm and Heart Failure division, is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), specifically the ICD CROME VR MRI IS1 DF1 (Model Number DVPC3D1). Approximately 510 units are affected by this recall.
The devices contain a specific glassed feedthrough component that has a rare potential to malfunction. When this occurs, the device may produce reduced or no electrical energy output during high voltage therapy, which is typically delivered at 0-12 joules. This therapy is used to treat dangerous heart rhythm disturbances.
The affected devices have been distributed nationwide and have been shipped worldwide. Patients with these devices should consult their healthcare provider regarding this potential defect and its implications for their care.
The recalled product
- Product
- ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators
- Affected units
- 510
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)
- GTIN 00763000178536
- Lot Serial Numbers: RSG600215S
- RSG600106S
- RSG600196S
- RSG600208S
- RSG600223S
- RSG600280S
- RSG600125S
- RSG600193S
- RSG600006S
- RSG600016S
- RSG600123S
- RSG600136S
- RSG600573S
- RSG600113S
- RSG600249S
- RSG600395S
- RSG600579S
- RSG600173S
- RSG600111S
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 120 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 120 products in this recall →Related recalls
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