Recall Z-0965-2022 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
St. Jude Medical, Cardiac Rhythm Management Division
Merlin 2 PCS MER3700 programmer Model MER3400 software
| Date | Mar 10, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| 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 Tes |
| Quantity | 401 devices with software |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.