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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 ICMsee related information
Date Initiated by FirmJanuary 18, 2022
Create DateMarch 11, 2022
Recall Status1 Terminated 3 on May 04, 2026
Recall NumberZ-0782-2022
Recall Event ID 89469
510(K)NumberK200795 
Product Classification Recorder, event, implantable cardiac, (with arrhythmia detection) - Product Code MXD
ProductLINQ 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)
FEI Number 2182208
Recalling Firm/
Manufacturer		 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information ContactTechnical 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
ActionOn 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 Commerce8 devices
DistributionWorldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MXD
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