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FDA (Device enforcement)Recalled 2022-01-18closedclass ii

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): LINQ II Insertable Cardiac Monitor

Is my product affected?

LINQ II Insertable Cardiac Monitor

  • UPC 00763000060374
  • UPC 00763000060381
  • UPC 00763000554002

Check against the official notice below — it lists the full affected range.

What happened

Medtronic Inc. is recalling eight LINQ II Insertable Cardiac Monitor devices that may lose functionality due to moisture getting inside the devices. The affected devices were distributed worldwide, with US distribution in New Jersey, New York, Pennsylvania, and Virginia, as well as distribution in Italy. Only eight specific devices are impacted by this recall, each identified by individual serial numbers.

The recall notice does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Devices may lose functionality due to susceptibility to moisture ingress.

Details from the source

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. Quantity: 8 devices 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)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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