ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
Check against the official notice below — it lists the full affected range.
St. Jude Medical is recalling approximately 95,042 Endurity pacemakers manufactured between 2015 and 2018 due to a manufacturing issue with the epoxy mixing process used in device production. The defect may allow moisture to enter through the device header and feedthrough, which could cause the pacemakers to malfunction. The recalled models include PM1160, PM2160, PM1152, PM2152, PM1172, and PM2172, and affected devices have been distributed worldwide, including throughout all U.S. states and territories and numerous countries internationally.
The specific serial numbers of affected pacemakers are listed in the recall record. The source document does not specify what remedy or action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 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): [806 Amendment - after March 2021 - updated 3/20/2023] Algeria, Angola, Argentina, Aruba, Australia, Aus Quantity: 95,042 pacemakers [updated 03/20/2023] Lot/code info: Endurity Pacemaker Model Number/UDI (GTIN): PM1160 / 05414734507042 PM2160 / 05414734507059 PM1152 / 05414734509763 PM2152 / 05414734509770 PM1172 / 05414734509596 PM2172 / 05414734509602 Serial Numbers: 7649831 7650690 7650710 7650712 7650713 7650715 7650718 7650727 7650742 7650800 7650801 7650802 7650806 7650809 7650811 7650815 7650816 7650817 7650818 7650820 7650821 7650822 7650823 7650824 7650826 7650969 7650971 7650974 7650975 7650976 7650978 7650979 7650980 7650982 7650983 7650984 7650985 7650986 7650987 7650988 7650989 7650990 7650992 7650993 7650994 7650995 7650997 7650998 7651000 7651001 7651002 7651004 7651005 7651006 7651008 7651010 7651011 7651012 7651014 7651015 7651016 7651017 7651018 7651019 7651020 7651021 7651023 7651024 7651027 7651028 7651169 7651171 7651172 7651173 7651174 7651175 7651176 7651177 7651179 7651180 7651181 7651182 7651183 7651185 7651186 7651187 7651188 7651189 7651190 7651191 7651192 7651193 7651194 7651196 7651197 7651198 7651199 7651200 7651201 7651202 7651204 7651205 7651206 7651207 7651208 7651211 7651213 7651214 7651215 7651216 7651218 7651220 7651221 7651222 7651223 7651225 7651226 7651228 7651339 7651340 7651341 7651342 7651344 7651345 7651347 7651348 7651349 7651350 7651351 7651352 7651354 7651355 7651356 7651357 7651359 7651360 7651361 7651362 7651364 7651366 7651367 7651368 7651369 7651370 7651371 7651372 7651373 7651374 7651375 7651376 7651377 7651380 7651381 7651382 7651383 7651384 7651386 7651388 7651389 7651390 7651391 7651392
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.