Cobalt Implantable Defibrillators May Deliver Reduced Shock Energy
Medtronic Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. The reduced energy could affect device performance in patients requiring defibrillation.
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: The FDA classified this as a Class I recall, which requires a minimum severity score of 4. Although no injuries or deaths have been reported, the potential for reduced shock energy output could impair life-critical defibrillation therapy function.
Plain-English summary
Medtronic Inc. is recalling certain Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The affected Cobalt models include Cobalt HF CRT-D (models DTPB2D4, DTPB2D1) and Cobalt HF Quad CRT-D (models DTPB2QQ, DTPB2Q1). Approximately 1,408 units of these devices have been distributed worldwide.
The recalled devices may deliver reduced shock energy during high-voltage therapy, delivering approximately 79% of the programmed energy instead of the full amount. This reduced energy delivery could affect the devices' ability to deliver appropriate defibrillation therapy.
Patients with these implanted devices should consult their healthcare provider or Medtronic regarding whether their specific device is affected, based on the device model number and serial number.
The FDA has classified this as a Class I recall.
The recalled product
- Product
- Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
- Affected units
- 1,408
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)
- a. Model Numbers: DTPB2D4: GTIN 00763000178215
- Serial Numbers: RTO600239S
- RTO600280S
- RTO600409S
- RTO600468S
- RTO600544S
- RTO600701S
- RTO600712S
- RTO601012S
- RTO601031S
- RTO601113S
- RTO601150S
- RTO601156S
- RTO601205S
- RTO601223S
- RTO601549S
- RTO601612S
- RTO601620S
- RTO601784S
- RTO601793S
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 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 6 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 shock energy
See all →- SevereCobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy
FDA (Devices) · 2022-08-17
- SevereMedtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect
FDA (Devices) · 2022-08-17
- SevereCrome Implantable Cardioverter Defibrillators Recalled for Reduced Shock Energy
FDA (Devices) · 2022-08-17
- SevereCobalt Implantable Cardioverter Defibrillators May Deliver Reduced Shock Energy
FDA (Devices) · 2022-08-17
Similar recalls
- SevereImplantable Defibrillators May Deliver Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillators May Deliver Reduced Energy During High Voltage Therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators Risk Energy Output Failure
FDA (Devices) · 2023-06-28
- SevereMedtronic ICD COBALT XT implants may deliver reduced or no therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators May Fail Therapy Energy Delivery
FDA (Devices) · 2023-06-28
- CriticalImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output During Therapy
FDA (Devices) · 2023-06-28