Open, Classified

Merlin PCS 3650 programmer Model 3330 software

FDA Recall Z-0964-2022 · Posted None

Recalling FirmSt. Jude Medical, Cardiac Rhythm Management Division

Recall StatusOpen, Classified

Product CodeOSR

Date Initiated2022-03-10

Product Quantity30,069 devices with software

Reason for Recall

Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.

Firm Action

The Recalling firm is sending an "Urgent Medical Device Correction" Letter to physicians and healthcare professionals informing them of a programmer software anomaly that may be encountered when executing a pacing capture Decrement Test in-clinic on a Gallant, or Entrant device using a Merlin Patient Care System (PCS) programmer. If a user presses the Hold to Test button and decides to stop testing by releasing the button prior to the first voltage decrement (within a narrow time window approximately 2.5 seconds after test initiation), the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters. Customers instructions/recommendations regarding patient management: The Recalling Firm has developed updated software (v25.4X rev 1 or higher) which will correct this issue. A Recalling Firm Representative will be upgrading the programmer software beginning in March 2022. For any questions, contact Abbott Technical Support at 1-800-722-3774.

Root Cause

Software design

Distribution Pattern

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI and WY. The countries of Argentina, Australia, AUSTRIA, Bahrain, Bangladesh, BELGIUM, Brazil, Bulgaria, Canada, Chile, COLOMBIA, COSTA RICA, Cyprus, Czech republic, DENMARK, ECUADOR, Egypt, Estonia, Faroe Islands, FINLAND, FRANCE, French Guiana, French Polynesia, GERMANY, Greece, Greenland, Guadeloupe, HUNGARY, Iceland, India, IRELAND, ITALY, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Liechtenstein, LITHUANIA, Luxembourg, Malaysia, Malta, Martinque, Mayotte, MEXICO, Nepal, NETHERLANDS, New Caledonia, New Zealand, NORWAY, Oman, Pakistan, Palestine, POLAND, PORTUGAL, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, SPAIN, Srilanka, SWEDEN, SWITZERLAND, Thailand, UAE, and UNITED KINGDOM.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.