Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Certain Medtronic implantable cardioverter defibrillators (ICDs and CRT-Ds) may fail to deliver critical therapy due to a manufacturing defect in the feedthrough. This rare issue affects 23,223 devices.
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 recall classification establishes a minimum severity of 4. While the manufacturer characterizes the malfunction risk as rare and no illnesses have been reported, the potential for therapy failure in a life-critical implantable cardiac device justifies this classification.
Plain-English summary
Medtronic is recalling certain CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) containing a specific glassed feedthrough component. Approximately 23,223 units have been distributed in the United States and worldwide.
There is a rare potential for these devices to produce reduced or no-energy output during high-voltage (HV) therapy, typically in the 0-12 joule range. This defect is in a specific feedthrough component used during manufacturing. If the device fails to deliver therapy, it could prevent critical shock therapy from being administered when needed.
Patients with affected devices should contact their healthcare provider or Medtronic immediately to discuss individual risk and determine whether device replacement or additional monitoring is appropriate. The manufacturer provides lot serial numbers to identify affected devices. Patients should not attempt device replacement without medical guidance.
The recalled product
- Product
- CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-failure
- device-defect
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 00643169720640
- Lot Serial Numbers: RPB618471S
- RPB621777S
- RPB619798S
- RPB622872S
- RPB620883S
- RPB621725S
- RPB612828S
- RPB605719S
- RPB615701S
- RPB605409S
- RPB609214S
- RPB619400S
- RPB611888S
- RPB603955S
- RPB617094S
- RPB610684S
- RPB603737S
- RPB603739S
- RPB603852S
Distribution
Distributed nationwide across the United States.
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