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U.S. Department of Health and Human Services

Class 2 Device Recall LINQ II ICM

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  Class 2 Device Recall LINQ II ICM see related information
Date Initiated by Firm January 18, 2022
Create Date March 11, 2022
Recall Status1 Open3, Classified
Recall Number Z-0782-2022
Recall Event ID 89469
510(K)Number K200795  
Product Classification Recorder, event, implantable cardiac, (with arrhythmia detection) - Product Code MXD
Product LINQ II Insertable Cardiac Monitor
Code Information 8 impacted devices with the following Serial number and GTIN 1) Serial RLB035341G (GTIN 00763000060374) 2) Serial RLB051224G (GTIN 00763000060374) 3) Serial RLB059666G (GTIN 00763000060374) 4) Serial RLB061064G (GTIN 00763000060374) 5) Serial RLB061812G (GTIN 00763000060381) 6) Serial RLB066367G (GTIN 00763000060374) 7) Serial RLB091638G (GTIN 00763000060374) 8) Serial RLB122769G (GTIN 00763000554002)
Recalling Firm/
Manufacturer		 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information Contact Technical Services
800-929-4043
Manufacturer Reason
for Recall		 Devices may lose functionality due to susceptibility to moisture ingress.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On or around January 18, 2002, in the United States, Medtronic will begin notifying notified customers of the field corrective action and patient management recommendations via 2-day UPS delivery. Consignees were provided with proper patient management recommendations. Consignees are asked to complete and return a confirmation certification confirming they have received the notification. Outside the United States (OUS), communication will begin no later than 18-JAN-2022 using locally approved methods.
Quantity in Commerce 8 devices
Distribution Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
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.
510(K) Database 510(K)s with Product Code = MXD and Original Applicant = Medtronic, Inc.
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