Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Certain Medtronic implantable cardioverter defibrillators (ICDs and CRT-Ds) may fail to deliver critical therapy due to a manufacturing defect in the feedthrough. This rare issue affects 23,223 devices.
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: FDA Class I recall classification establishes a minimum severity of 4. While the manufacturer characterizes the malfunction risk as rare and no illnesses have been reported, the potential for therapy failure in a life-critical implantable cardiac device justifies this classification.
Plain-English summary
Medtronic is recalling certain CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) containing a specific glassed feedthrough component. Approximately 23,223 units have been distributed in the United States and worldwide.
There is a rare potential for these devices to produce reduced or no-energy output during high-voltage (HV) therapy, typically in the 0-12 joule range. This defect is in a specific feedthrough component used during manufacturing. If the device fails to deliver therapy, it could prevent critical shock therapy from being administered when needed.
Patients with affected devices should contact their healthcare provider or Medtronic immediately to discuss individual risk and determine whether device replacement or additional monitoring is appropriate. The manufacturer provides lot serial numbers to identify affected devices. Patients should not attempt device replacement without medical guidance.
The recalled product
- Product
- CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators
- Affected units
- 23,223
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 00643169720640
- Lot Serial Numbers: RPB618471S
- RPB621777S
- RPB619798S
- RPB622872S
- RPB620883S
- RPB621725S
- RPB612828S
- RPB605719S
- RPB615701S
- RPB605409S
- RPB609214S
- RPB619400S
- RPB611888S
- RPB603955S
- RPB617094S
- RPB610684S
- RPB603737S
- RPB603739S
- RPB603852S
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 · therapy failure
See all →- HighImplantable Vagus Nerve Stimulation Device May Stop Delivering Therapy
FDA (Devices) · 2025-02-05
- HighV.A.C. Ulta Therapy Units Recalled Due to Occlusion Sensor Failures
FDA (Devices) · 2024-12-04
- HighReplacement Lead Wires Recalled for Risk of Treatment Delivery Failure
FDA (Devices) · 2024-05-01
- HighOPTIMIZER CCM X11 Implantable Pulse Generator May Fail to Deliver Therapy
FDA (Devices) · 2024-02-28
- SeverePercussionaire Distal Phasitron respiratory device with reservoir bag assembly defect recalled
FDA (Devices) · 2024-01-24
Similar recalls
- HighMedtronic Implantable Defibrillators Recalled for Manufacturing Weld Defect
FDA (Devices) · 2024-07-03
- HighMedtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect
FDA (Devices) · 2024-07-03
- HighMedtronic Implantable Defibrillator Recalled for Manufacturing Weld Defect
FDA (Devices) · 2024-07-03
- SevereMedtronic Visia AF ICDs Recalled for Potential Therapy Failure
FDA (Devices) · 2018-02-28
- HighMedtronic Implantable Defibrillator Recalled Due to Manufacturing Weld Crack
FDA (Devices) · 2024-07-03
- CriticalMedtronic Recalls Compia MRI CRT-Ds Due to Therapy Prevention Risk
FDA (Devices) · 2018-02-28