Implantable Cardioverter Defibrillators Recalled for Potential Reduced Energy Output
Medtronic implantable cardioverter defibrillators (ICDs) and CRT-Ds with specific feedthrough designs may produce reduced or insufficient energy during high voltage therapy, affecting the device's ability to treat heart arrhythmias.
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 designation reflects the agency's determination that there is a reasonable probability of serious adverse health consequences or death. Although the hazard is rare and no adverse events have been reported, the Class I classification requires a minimum severity score of 4 per the rubric.
Plain-English summary
Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that were manufactured with a specific glassed feedthrough. The affected model is the ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT. Approximately 35,961 units have been distributed in the United States and worldwide.
There is a rare potential for reduced or no energy output during high voltage therapy (typically 0-12 joules) in these devices. This hazard could prevent the device from delivering the electrical therapy necessary to treat life-threatening heart arrhythmias. The FDA classified this recall as Class I, indicating a serious risk to health and safety.
Patients with these implanted devices should confirm their device model and serial number and contact their healthcare provider or Medtronic for specific information about their device and whether additional evaluation is needed.
The recalled product
- Product
- ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators
- Category
- Medical Device — Cardiovascular
- Affected units
- 35,961
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 00643169443419
- Lot Serial Numbers: PGZ624363S
- PGZ631078S
- PGZ638449S
- PGZ638465S
- PGZ623851S
- PGZ645877S
- PGZ621671S
- PGZ621673S
- PGZ623094S
- PGZ623561S
- PGZ623984S
- PGZ623985S
- PGZ623986S
- PGZ623991S
- PGZ624447S
- PGZ626933S
- PGZ626995S
- PGZ627005S
- PGZ627071S
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)
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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
- CriticalMedtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure
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