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.
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: 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)
See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
Same hazard · reduced energy output
See all →- 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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