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U.S. Department of Health and Human Services

Class 2 Device Recall COBALT XT HF QUAD CRTD MRI SureScan

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 Class 2 Device Recall COBALT XT HF QUAD CRTD MRI SureScansee related information
Date Initiated by FirmApril 16, 2024
Date PostedJune 26, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2194-2024
Recall Event ID 94674
PMA NumberP980016S382 
Product Classification Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
ProductCOBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
Code Information GTIN: 00763000178093, Serial Number: RTC656756S; GTIN: 00763000178116, Serial Numbers: RTC656044S, RTC656047S, RTC656049S, RTC656061S, RTC656065S, RTC656070S, RTC656072S, RTC656099S, RTC656100S, RTC656102S, RTC656103S, RTC656104S, RTC656105S, RTC656106S, RTC656107S; GTIN: 00763000711160, Serial Numbers: RTC655925S, RTC655928S, RTC655930S, RTC655931S, RTC655932S, RTC655938S, RTC655945S, RTC655947S, RTC655950S, RTC655964S, RTC655971S, RTC656073S, RTC656074S, RTC656076S, RTC656077S, RTC656078S, RTC656080S, RTC656082S, RTC656087S, RTC656090S, RTC656093S, RTC656095S, RTC656096S, RTC656587S, RTC656589S, RTC656590S, RTC656592S, RTC656602S, RTC656603S, RTC656606S, RTC656607S, RTC656608S, RTC656609S, RTC656610S, RTC656615S, RTC656616S, RTC656619S, RTC656625S, RTC656626S, RTC656627S, RTC656628S, RTC656630S
Recalling Firm/
Manufacturer		 Medtronic Inc.
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information ContactTracy McNulty
763-505-6000
Manufacturer Reason
for Recall		Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn about 04/18/2024, Medtronic notified customers that they were retrieving distributed units that may have undergone a specific manufacturing sequence that requires additional engineering evaluation. They requested that customers acknowledge the letter with signature.
Quantity in Commerce58 units
DistributionWorldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
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.
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