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.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with…"
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
- Affected units
- 11,239
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.
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)
See all →- CriticalMedtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
FDA (Devices) · 2023-06-28
Same hazard · reduced energy output
See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereImplantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable defibrillators may deliver reduced or no energy during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable cardioverter defibrillators may output reduced or no energy during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators Recalled for Potential Reduced Energy Output
FDA (Devices) · 2023-06-28
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