Recalls / —

—#191703

Product

LINQ II Insertable Cardiac Monitor

FDA product code

MXD — Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K200795

Affected 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)

Why it was recalled

Devices may lose functionality due to susceptibility to moisture ingress.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Address

8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.

Timeline

Recall initiated

2022-01-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #191703. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.