LINQ II Insertable Cardiac Monitor
Summary
The FDA issued a Class II for LINQ II Insertable Cardiac Monitor by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Reason: Devices may lose functionality due to susceptibility to moisture ingress..
Details
Source
Device Recall
External ID
Z-0782-2022
Action Date
2022-03-23
Status
Terminated
Category
device
Product Description
LINQ II Insertable Cardiac Monitor
Lot/Code Info: 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)
Quantity Affected: 8 devices
Reason for Recall
Devices may lose functionality due to susceptibility to moisture ingress.
Distribution
Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-18
Company
Mounds View, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 145 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 138 FDA actions in our database, including 138 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) have FDA actions?
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 138 FDA actions in our database, including 138 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0782-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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