Medtronic Implantable Cardioverter Defibrillator Model DTPA2D1G Therapy Output Failure
Medtronic Inc. is recalling five units of the CRTD DTPA2D1G COBALT XT HF QUAD OUS implantable cardioverter defibrillator due to a rare potential for reduced or no energy output during high-voltage defibrillation therapy.
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 device is subject to an FDA Class I recall; however, no deaths or serious injuries have been reported and the hazard is described as a rare potential for device failure, preventing a Critical classification.
Plain-English summary
Medtronic Inc. is recalling five units of the CRTD DTPA2D1G COBALT XT HF QUAD OUS implantable cardioverter defibrillator (model DTPA2D1G). The devices are affected by a rare potential for reduced or no energy output during high-voltage therapy, typically in the 0-12 joule range.
The affected devices contain a specific glassed feedthrough component that may cause this malfunction. The recalled units have the following lot serial numbers: RTH602452S, RTH602446S, RTH602443S, RTH602454S, and RTH602442S. These devices were distributed nationwide in the United States and worldwide.
The recalled product
- Product
- CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter Defibrillators
- Affected units
- 5
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 (6)
- GTIN 00763000501044
- lot serial Numbers: RTH602452S
- RTH602446S
- RTH602443S
- RTH602454S
- RTH602442S
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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