Medtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect
Medtronic has recalled 8,429 Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) worldwide due to potential reduced shock energy during therapy, potentially delivering 79% of programmed energy.
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 medical device recall, which by regulatory definition indicates a serious risk to health or safety. The Class I designation establishes the minimum severity threshold regardless of reported injuries. The potential for reduced therapy effectiveness in life-critical devices warrants the Severe classification.
Plain-English summary
Medtronic Inc. has issued a worldwide recall of certain Cobalt implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The recalled models are Cobalt XT HF CRT-D (Models DTPA2D4, DTPA2D1) and Cobalt XT HF Quad CRT-D (Models DTPA2QQ, DTPA2Q1). A total of 8,429 units have been identified as affected by this recall.
The devices have a potential defect that could result in reduced shock energy during high-voltage (HV) therapy, with affected devices potentially delivering approximately 79% of the programmed energy. This reduced energy output may impact the device's ability to successfully terminate life-threatening cardiac arrhythmias.
Patients implanted with affected devices are identified by specific serial numbers listed in the FDA recall notice. Healthcare providers should verify whether a patient's device is included in the recall by checking the device's serial number and model number. Patients with affected devices should consult with their implanting physician regarding appropriate follow-up and potential management options.
The recalled product
- Product
- Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
- Affected units
- 8,429
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: DTPA2D4: GTIN 00763000178130
- Serial Numbers: RTG600136S
- RTG600270S
- RTG601323S
- RTG601338S
- RTG601367S
- RTG601433S
- RTG601484S
- RTG601489S
- RTG601575S
- RTG601583S
- RTG601595S
- RTG601632S
- RTG601643S
- RTG601653S
- RTG601657S
- RTG601669S
- RTG601775S
- RTG601790S
- RTG601802S
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)
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Same hazard · reduced shock energy
See all →- SevereCobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy
FDA (Devices) · 2022-08-17
- SevereCrome Implantable Cardioverter Defibrillators Recalled for Reduced Shock Energy
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- SevereCobalt Implantable Cardioverter Defibrillators May Deliver Reduced Shock Energy
FDA (Devices) · 2022-08-17
- SevereCobalt Implantable Defibrillators May Deliver Reduced Shock Energy
FDA (Devices) · 2022-08-17
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