Implantable Cardiac Defibrillators May Deliver Reduced Energy Output
Certain Medtronic cardiac defibrillators may deliver reduced or no energy during high voltage therapy. No injuries or deaths have been reported.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with…"
Plain-English summary
Medtronic Inc. is recalling certain CRTD DTMA1D4 CLARIA MRI US DF4 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators (approximately 12,291 units). These devices may deliver reduced or no energy output during high voltage therapy due to a defect in a specific type of feedthrough component.
High voltage therapy, typically delivered at 0-12 joules, is critical for treating life-threatening heart rhythms. When a device is manufactured with the specific glassed feedthrough at issue, there is a rare potential that the device will not deliver adequate energy during therapy.
The affected devices were distributed nationwide and internationally. No deaths, injuries, or illnesses related to this issue have been reported to the FDA as of this recall.
The recalled product
- Product
- CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
- Affected units
- 12,291
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 00643169720657
- Lot Serial Numbers: RPC203306H
- RPC205335H
- RPC207546H
- RPC210227H
- RPC205865H
- RPC205916H
- RPC205937H
- RPC206296H
- RPC206416H
- RPC206665H
- RPC207309H
- RPC207864H
- RPC208393H
- RPC209253H
- RPC209691H
- RPC209707H
- RPC209745H
- RPC209762H
- RPC209847H
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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