Cobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy
Medtronic's Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. Patients with affected models should contact their physician.
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 medical device recall, which establishes a minimum severity score of 4 per the rubric. The hazard is potential rather than confirmed, and no reported illnesses or deaths are mentioned in the source, preventing a higher classification.
Plain-English summary
Medtronic Inc. has recalled certain Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The affected models include the Cobalt XT VR ICD (models DVPA2D1 and DVPA2D4) and the Cobalt XT DR ICD (models DDPA2D1 and DDPA2D4). Approximately 6,884 units have been distributed worldwide. Specific affected serial numbers are listed in the official FDA recall notice.
These devices have the potential to deliver reduced shock energy—approximately 79% of the programmed energy—during high-voltage therapy. The reduced energy output could compromise the device's ability to effectively treat dangerous heart rhythms in patients who depend on the defibrillation therapy.
Patients who have received these specific devices should contact their implanting cardiologist or Medtronic directly to determine whether their device is affected. Healthcare providers should evaluate each patient's device to assess the need for monitoring, firmware updates, or replacement. Patients should continue using their device as prescribed and should not discontinue therapy without guidance from their physician.
The recalled product
- Product
- Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
- Affected units
- 6,884
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: DVPA2D1: GTIN 00763000178451
- Serial Numbers: RSC600237S
- RSC600256S
- RSC600277S
- RSC600327S
- RSC600419S
- RSC601038S
- RSC601061S
- RSC601065S
- RSC601084S
- RSC601126S
- RSC601134S
- RSC601138S
- RSC601158S
- RSC601159S
- RSC601175S
- RSC601193S
- RSC601209S
- RSC601210S
- RSC601213S
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 →- SevereMedtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect
FDA (Devices) · 2022-08-17
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