Recall Z-1530-2021 ยท NVZ Pulse Generator, Permanent, Implantable
St. Jude Medical, Cardian Rhythm Management Division
ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
| Date | May 7, 2021 (initiated Mar 15, 2021) |
| Status | Open, Classified |
| Reason | Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough |
| Root cause | Process control |
| Action | On 10/5/2021, the firm notified additional customer via a "Safety Notification Update" letter due to finding additional affected products after March 2021. The instructions from the 3/15/2021 original letter still applies. Issue of the update remains, the issue is caused by intermittent incomplete mixing of epoxy during manufacture, which may allow moisture ingress into the pulse generator header. As a result, the potential for affected clinical impact has included loss of telemetry/communication, reduced battery longevity, loss of pacing, and/or shortened duration between Elective Replaceme |
| Quantity | 242,945 pacemakers [updated 3/20/2023] |
| Distribution | Worldwide distribution: U.S (nationwide) to states including.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.( countries): [8 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.