Class 2 Device Recall Medtronic LINQ II

• Date Initiated by Firm: May 14, 2021
• Date Posted: July 14, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2076-2021
• Recall Event ID: 88089
• 510(K)Number: K200795
• Product Classification: Recorder, event, implantable cardiac, (with arrhythmia detection) - Product Code MXD
• Product: Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
• Code Information: Model Number: LNQ22
• Recalling Firm/ Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF); 8200 Coral Sea St Ne; Mounds View MN 55112-4391
• For Additional Information Contact: Technical SErvices; 800-929-4043
• Manufacturer Reason for Recall: Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
• FDA Determined Cause: Software design
• Action: On June 1 2021 Medtronic sent a letter notifying the consignees the following: -LINQ II insertable cardiac monitors (ICM) that undergo a partial electrical reset appear to be programmed ON, but are no longer able to detect and report Brady, Pause, and PVC events to clinicians. Medtronic estimates that 0.21% of LINQ II ICMs have experienced a partial electrical reset resulting in the inability to detect Brady, Pause, and PVC events. -A correction for currently implanted LINQ II ICMs is not available. -We are requesting that hospitals quarantine all LINQ II ICMs on hospital shelves. Physicians should cease implanting any remaining LINQ II ICMs that may remain in shelf stock and return any unused product to Medtronic. -There will be an update for future manufactured LINQ II ICMs, which is anticipated to be available in the U.S. July 2021. UPDATE: On June 16 2021, the firm sent an updated letter to inform their consignees of the availability of LINQ II Insertable Cardiac Monitors (ICMs) with an FDA cleared update addressing the issue referenced in the June 2021 letter. Updated LINQ II ICMs will not be susceptible to the potential for disabled Brady, Pause, and PVC detection after a partial electrical reset. Note that: - Initial supply of the updated LINQ II ICMs may be limited. - LINQ II ICMs manufactured prior to the approval of this update cannot be corrected in the field. ---- LINQ II ICMs implanted prior to the release of this update will continue to be susceptible to this issue. - Please continue to return all unused, affected LINQ II ICMs in your inventory to Medtronic. Contact Customer Service at 1-800-848-9300, or your local Medtronic Representative to assist you with a product return. UPDATE: On 08/02/2023, Medtronic sent another notification advising consignees of the availability of a software update for identified LINQ II ICMs.
• Quantity in Commerce: 21,685
• Distribution: Worldwide distribution - US Nationwide in the states of AK, AL, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. The countries of Australia, Austria, Canada, Denmark, Finland, Germany, Ireland, Italy, Netherlands, Netherlands Antilles, Sweden, Switzerland, and United Kingdom.
• Total Product Life Cycle: TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MXD and Original Applicant = Medtronic, Inc.