Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Reveal LINQ

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Medtronic Reveal LINQsee related information
Date Initiated by FirmJune 01, 2021
Create DateJuly 20, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2102-2021
Recall Event ID 88175
510(K)NumberK162855 
Product Classification Recorder, event, implantable cardiac, (with arrhythmia detection) - Product Code MXD
ProductMedtronic Reveal LINQ LNQ11 / PA96000
Code Information All serial numbers distributed on or after February 23, 2017    GTIN: 643169845763, 643169845770, 643169845787, 643169845794, 643169845800, 643169845817, 643169845824, 00643169845831, 00643169845848, 00643169845855, 00643169845862, 00643169845879, 00643169845893, 00763000188382, 00763000188399, 00763000188405, 00763000188412, 00763000188429, 00763000188436, 00763000188443, 00763000188450, 00763000188467, 643169845688, 643169845695, 643169845701, 643169845718, 643169845732, 643169845749, 643169845756   
Recalling Firm/
Manufacturer		 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information ContactTechnical Services
800-929-4043
Manufacturer Reason
for Recall		Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.
FDA Determined
Cause 2		Software design
ActionThe firm began notifying their consignees on 06/02/2021 by letter. The letter explained the issue, provided patient management recommendations, and reported that a software update was anticipated in late 2021. For questions, contact your local Medtronic Representative or Medtronic Technical Services at 800-929-4043.
Quantity in Commerce666210 devices
DistributionWorldwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MXD
-
-