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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Cobalt

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 Class 2 Device Recall Medtronic Cobaltsee related information
Date Initiated by FirmDecember 07, 2023
Date PostedJanuary 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0779-2024
Recall Event ID 93663
PMA NumberP980016S713 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
ProductCobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Code Information UDI/DI 00763000178338, Serial Number RSL604096S
FEI Number 2182208
Recalling Firm/
Manufacturer		 Medtronic Inc.
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information ContactKathleen Janasz
763-505-6000
Manufacturer Reason
for Recall		During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionMedtronic hand delivered an Urgent Medical Device Recall/Retrieval notice to its sole consignee on 12/07/2023. The notice explained the issue and indicated that the device would be collected and a replacement provided.
Quantity in Commerce1 device
DistributionUS Nationwide distribution in the state of Florida.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = LWS
PMAs with Product Code = LWS
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