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U.S. Department of Health and Human Services

Class 2 Device Recall Merlin PCS Programmer Software

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  Class 2 Device Recall Merlin PCS Programmer Software see related information
Date Initiated by Firm April 16, 2018
Create Date June 29, 2018
Recall Status1 Terminated 3 on February 04, 2021
Recall Number Z-2335-2018
Recall Event ID 80244
510(K)Number K163407  
Product Classification Recorder, event, implantable cardiac, (without arrhythmia detection) - Product Code MXC
Product Merlin PCS Programmer Software: 3330

The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.
Code Information Software Versions: 24.0.1 rev 1
Recalling Firm/
St Jude Medical Inc.
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact Justin Paquette
Manufacturer Reason
for Recall
The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm, Abbott, sent an "URGENT MEDICAL DEVICE CORRECTION" letters dated 05/18/2018, to its consignees notifying them that updated programmer software version 24.2.x will be made available over the next several weeks and will allow physicians to detect the presence of incorrect battery indicator prior to implant. Additionally, the programmer software will provide a mechanism to resolve the incorrect display for already implanted devices. If a low battery indicator is observed, customers were advised to contact firm technical services at 1-800-722-3774 to assist in confirmation and correction of the battery indicator display.
Quantity in Commerce 0
Distribution U.S. Nationwide Distribution: PR, MI, NJ, IL, FL, AR, PA, KY, CA, TN, IN, AL, TX, AZ, SC, OK, VA, NH, NM, WA, CO, IA, WI, NV, UT, OH, NC, MO, DE, WV, MD, OR, NE, VT, KS, MA, IA, WY, CT, GA, MS, LA, DC, LA,
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MXC and Original Applicant = St. Jude Medical, Inc.