Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Brand
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Lot Codes / Batch Numbers
Model Number: LNQ22
Products Sold
Model Number: LNQ22
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only due to Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026