Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Cobalt

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Medtronic Cobalt see related information
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
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 Database PMAs with Product Code = LWS and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = LWS and Original Applicant = Medtronic, Inc.
-
-