Implantable Defibrillators May Fail to Deliver Critical Heart Therapy
Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy delivery due to a defective feedthrough component. No injuries have been reported, but patients may not receive proper treatment for life-threatening heart rhythms.
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: FDA Class I recall of a critical medical device designed to deliver life-saving defibrillation therapy. While no injuries or illnesses have been reported, the defect represents a serious potential health risk that could prevent therapy delivery when needed.
Plain-English summary
Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model DTPA2QQ, branded as COBALT XT HF QUAD MRI. These devices are used to prevent sudden cardiac death by detecting dangerous heart rhythms and delivering electrical therapy. Approximately 27,788 units with specific lot serial numbers are affected, distributed nationwide and worldwide.
The recalled devices contain a specific glassed feedthrough component that can result in reduced or no energy output during high-voltage therapy delivery, typically at 0-12 joules. This rare potential defect could prevent the device from delivering the critical electrical shock needed to correct life-threatening heart arrhythmias. The FDA classified this recall as Class I, indicating the highest level of health hazard.
The recalled product
- Product
- CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter Defibrillators
- Affected units
- 27,788
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 00763000178093
- Lot Serial Numbers: RTC605498S
- RTC605500S
- RTC605501S
- RTC605502S
- RTC607884S
- RTC607885S
- RTC608196S
- RTC608199S
- RTC608200S
- RTC610884S
- RTC610885S
- RTC610887S
- RTC610889S
- RTC610890S
- RTC610892S
- RTC626989S
- RTC626991S
- RTC626992S
- RTC626996S
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
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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