Class 2 Device Recall Merlin PCS Programmer Software

• Date Initiated by Firm: February 28, 2020
• Create Date: April 10, 2020
• Recall Status: Terminated on April 18, 2024
• Recall Number: Z-1700-2020
• Recall Event ID: 85275
• PMA Number: P030035S177 P910023S422 P030054S373
• Product Classification: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
• Product: Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical; ; The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
• Code Information: Software Version: 24.6.1 Model: 3650, GTIN: 05414734500661 Model: 3330, GTIN: 05414734509725 For affected serial number of programmers see Attachment B.1 Programmers For models of ICDs interrogated by affected programmers see Attachment B.2 Devices.
• Recalling Firm/ Manufacturer: Abbott; 15900 Valley View Ct; Sylmar CA 91342-3577
• For Additional Information Contact: Frank Gomez; 818-493-3591
• Manufacturer Reason for Recall: Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.
• FDA Determined Cause: Under Investigation by firm
• Action: On 02/28/2020, the frim sent all US consignees an "IMPORTANT MEDICAL DEVICE CORRECTION" letter via USPS three to five-day ground service. The customer notification informed customer that they had recently deployed a Patient Care System (PCS) programmer software that contained an anomaly that may result in specific programming changes not being stored in the device. The Recalling Firm explained that when using the affected programmer software to make certain programming changes, the changes may appear to have been successfully programmed but the device could remain at previously programmed settings. This issue can occur only if changes to tachycardia therapy Tilt or Waveform (monophasic/biphasic) settings are made and therapy energy value are modified from nominal using the new programmer software. The customer notification also informs customer of Patient Management Recommendations: The Recalling Firm has developed an updated programmer software version which will correct this issue. This solution does not present additional risks to patients and no intervention is needed for patients. The Recalling Firm will update the programmer software in the coming days. For any questions contact your representative or Technical Support at 1-800-722-3774 (U.S.).
• Quantity in Commerce: Software Version 24.6.1 installed into 4733 programmers
• Distribution: U.S. AK, Al, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: None - the firm stated that there are no OUS consignees associated to ICDs that were interrogated from January 22, 2020 to February 6, 2020.
• 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.

• PMA Database: PMAs with Product Code = NIK and Original Applicant = Abbott Medical