Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
Medtronic implantable cardiac defibrillators may deliver reduced or no energy during defibrillation therapy due to a feedthrough defect. Approximately 11,239 devices distributed worldwide are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class I FDA recall, but the source text describes a 'rare potential' for the hazard with no reported illnesses or deaths. Per the rubric exception for theoretical hazards with no reported illness, the score caps at 3 (High).
Plain-English summary
Medtronic Inc. is recalling certain Medtronic ICD-DR DDMD3D4 PRIMO MRI implantable cardioverter defibrillators (ICDs) and compatible cardiac resynchronization therapy defibrillators (CRT-Ds). These implantable heart devices contain a high-voltage feedthrough component that in rare instances may not function properly.
The feedthrough component may rarely result in reduced or no-energy output when the device attempts to deliver therapy during high-voltage defibrillation treatment, which typically occurs at energy levels of 0-12 joules. This means the devices may fail to deliver the necessary electrical therapy when needed to treat life-threatening irregular heart rhythms.
Approximately 11,239 units with the affected feedthrough component have been distributed across the United States and worldwide. Many of these devices are currently implanted in patients who depend on them to manage their heart conditions.
The recalled product
- Product
- ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- 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 00763000001506
- Lot Serial Numbers: CWN606940S
- CWN606941S
- CWN606806S
- CWN609866S
- CWN607173S
- CWN607174S
- CWN606850S
- CWN605016S
- CWN605224S
- CWN605226S
- CWN602473S
- CWN605696S
- CWN606066S
- CWN601517S
- CWN610794S
- CWN611698S
- CWN611709S
- CWN611042S
- CWN611699S
Distribution
Distributed nationwide across the United States.
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