Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling certain ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The recall affects 2,018 units distributed nationwide and worldwide.
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: This is an FDA Class I recall for implanted cardiac devices where a manufacturing defect could prevent delivery of life-critical high-voltage therapy. The potential for serious harm is inherent when a defibrillator fails to function as intended.
Plain-English summary
Medtronic Inc. is recalling specific implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough that may produce reduced or no energy output during high-voltage therapy delivery. These devices are designed to deliver high-voltage therapy (typically 0-12 joules) to treat dangerous heart rhythms.
The potential defect affects approximately 2,018 units that have been distributed nationwide and worldwide. The inability to deliver proper therapy poses a significant health risk for patients who rely on these devices.
Patients with these devices should contact their healthcare provider or Medtronic for information about whether their specific device is affected and what follow-up actions may be necessary.
The recalled product
- Product
- ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators
- Category
- Medical Device
- Affected units
- 2,018
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 00763000178437
- Lot Serial Numbers: RSQ600736S
- RSQ600745S
- RSQ600905S
- RSQ600975S
- RSQ601406S
- RSQ600113S
- RSQ600114S
- RSQ600115S
- RSQ600255S
- RSQ600256S
- RSQ600257S
- RSQ600258S
- RSQ600261S
- RSQ600740S
- RSQ601122S
- RSQ601137S
- RSQ601177S
- RSQ601178S
- RSQ601179S
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
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- 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
- CriticalMedtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure
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