Open, Classified

ASSURITY Pulse Generator REF PM SN ***** ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

FDA Recall Z-1530-2021 · Posted 2021-05-07

Recalling FirmSt. Jude Medical, Cardian Rhythm Management Division

Recall StatusOpen, Classified

Product CodeNVZ

Date Initiated2021-03-15

Product Quantity242,945 pacemakers [updated 3/20/2023]

Reason for Recall

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

Firm 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 Replacement Indicator (ERI) and End of Service (EOS). Physicians are provided with Patient Management Recommendations/Guidelines that include: 1) Prophylactic generator replacement is not recommended. This is due to the very low rate of occurrence, and the low potential for patient harm when prompt replacement is performed following an unexpected ERI/EOS alert. 2) Routine follow-up should remain as per standard of care and clinical protocol. - During follow-up, review any impact to device function including measured battery voltage or any unexpected change in battery consumption. - Evaluate potential for risk in patients who are pacemaker dependent and unable to be reliably followed using remote monitoring. 3) Prompt replacement for devices that reach ERI or EOS unexpectedly or experience one of the clinical impacts listed above commensurate with the patient s underlying clinical condition. 4) When possible, monitor patients using Merlin.net to benefit from alert monitoring between routine device checks. For patients currently enrolled in Merlin.net, remind them of the importance of using remote monitoring. ERI and EOS alerts are currently monitored daily. 5) Share this notification with others in their organization, as appropriate. Should you have any questions about this notice, please contact Abbott Technical Support at 1-800-722-3774 (U.S.). Please work with your Abbott Representat

Root Cause

Process control

Distribution Pattern

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): [806 Amendment - after March 2021 - updated 3/20/2023] Algeria, Angola, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Benin, Bolivia, Brazil, Bulgaria, Cameroon, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Korea, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Palestine, Panama, Paraguay, Peru Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Senegal, Servia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.

Official Source

View FDA Recall →

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