Medtronic Implantable Defibrillators Risk Failing to Deliver Electrical Therapy
Medtronic is recalling 404 units of implantable cardioverter defibrillators and cardiac resynchronization devices due to a rare risk of reduced or absent energy output during therapy. The defect involves a specific manufacturing feedthrough component.
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 classified as FDA Class I, which mandates a minimum severity rating of Severe. Although no illnesses or injuries have been reported, the potential for complete failure of critical therapy delivery in an implanted cardiac device represents a serious hazard.
Plain-English summary
Medtronic Inc. is recalling 404 units of the CRTD CROME HF QUAD MRI IS4 DF1 (Model DTPC2Q1) implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator (CRT-D) devices manufactured with a specific feedthrough component.
A rare potential exists for reduced or no-energy output during high-voltage therapy (typically 0-12 joules) in these devices. The defect is related to the specific type of feedthrough used in manufacturing.
These devices have been distributed throughout the United States and worldwide. The FDA has classified this as a Class I recall, indicating a serious hazard.
The recalled product
- Product
- CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators
- Affected units
- 404
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 00763000178260
- Lot Serial Numbers: RTT600077S
- RTT600166S
- RTT600169S
- RTT600064S
- RTT600083S
- RTT600071S
- RTT600042S
- RTT600028S
- RTT600107S
- RTT600034S
- RTT600421S
- RTT600432S
- RTT600434S
- RTT600574S
- RTT600161S
- RTT600054S
- RTT600160S
- RTT600231S
- RTT600431S
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 output
See all →- SevereImplantable Defibrillators May Fail to Deliver Therapy Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereImplantable Defibrillators May Have Reduced Energy Output During Therapy
FDA (Devices) · 2023-06-28
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