Date Initiated by Firm |
December 07, 2023 |
Date Posted |
January 22, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0779-2024 |
Recall Event ID |
93663 |
PMA Number |
P980016S713 |
Product Classification |
Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
|
Product |
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 |
Code Information |
UDI/DI 00763000178338, Serial Number RSL604096S |
Recalling Firm/ Manufacturer |
Medtronic Inc. 8200 Coral Sea St Ne Mounds View MN 55112-4391
|
For Additional Information Contact |
Kathleen 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 |
Action |
Medtronic 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 Commerce |
1 device |
Distribution |
US Nationwide distribution in the state of Florida. |
Total Product Life Cycle |
TPLC Device Report
|
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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.
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PMA Database |
PMAs with Product Code = LWS and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PMAs with Product Code = LWS and Original Applicant = Medtronic, Inc.
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