Medtronic Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
Medtronic issued a Class I recall for certain implantable cardioverter defibrillators due to a rare risk that high-voltage therapy may not deliver. Affected models include DTMA1QQ devices made with a specific feedthrough component.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. While no deaths or serious injuries are yet reported, the potential for reduced or absent therapy output in life-saving defibrillation devices represents a serious patient safety risk, warranting classification as Severe.
Plain-English summary
Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), specifically the CRTD DTMA1QQ CLARIA MRI QUAD US DF4 model. The recall affects 58,706 units worldwide. These devices are manufactured with a specific glassed feedthrough component that poses a potential safety risk.
The FDA has classified this as a Class I recall because there is a rare potential for reduced or absent high-voltage therapy output (typically 0-12 joules) during defibrillation treatment. This means the device may not deliver the electrical shock needed to correct a dangerous heart rhythm, which is the device's primary function.
Patients with affected ICDs or CRT-Ds manufactured with the identified feedthrough are at risk. The devices have been distributed nationwide in the United States and worldwide. Specific lot numbers for affected units are available through Medtronic and the FDA.
Patients should contact their healthcare provider or Medtronic immediately to determine if their device is affected. Do not discontinue use of the device without medical guidance. Patients should discuss replacement or remediation options with their cardiologist. More information is available from the FDA's CDRH medical device recall database.
The recalled product
- Product
- CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- therapy-failure
- device-malfunction
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 CRTD DTMA1QQ CLARIA MRI QUAD US DF4
- Lot Serial Numbers: RPA210493H
- RPA222265H
- RPA231080H
- RPA238029H
- RPA220160H
- RPA224981H
- RPA226922H
- RPA226926H
- RPA226931H
- RPA226935H
- RPA226936H
- RPA231700H
- RPA231701H
- RPA231707H
- RPA231708H
- RPA231711H
- RPA235632H
- RPA235645H
- RPA235649H
Distribution
Distributed nationwide across the United States.
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