FDAClass IIMarch 23, 2022

LINQ II Insertable Cardiac Monitor recall

LINQ II Insertable Cardiac Monitor

Why was LINQ II Insertable Cardiac Monitor recalled?

Devices may lose functionality due to susceptibility to moisture ingress.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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)

Product
LINQ II Insertable Cardiac Monitor
Recalling firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Quantity
8 devices
Distribution
Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
Recall date
March 23, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls