Device Recall Sigma Pacemaker

Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com. Model SD203: serial no. PJD182918H - PJD191025H, PJD432660H - PJD449026H, PJD674196S - PJD690881S, PJD731443S - PJD743447S. Model SD303: serial no. PJD183969H - PJD186285H, PJD187584H - PJD187735H, PJD190274H, PJD190305H, PJD190308H, PJD195395H, PJD195444H, PJD441326 - PJD448026H, PJD674200S - PJD681640S, PJD691135S, PJD691231S, PJD729895S - PJD742209S.

Cardiovascular Devices

3

Yes

Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America

Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303

Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com.  Model SDR203: serial no. PJD183978h - PJD184012h, PJD186200H - PJD186279H, PJD187571H - PJD187669H, PJD193734H, PJD195394H - PJD195470H, PJD442170H, PJD445718H - PJD452929H, PJD674175S - PJD680868S, PJD685590S, PJD689228S, PJD691226S, PJD731742S - PJD739835S. Model SDR 303: serial no. PJD182452H - PJD199059H, PJD205280H, PJD440288H - PJD451956H, PJD674216S - PJD691410S, PJD730124S - PJD746998S. Model SDR 306: serial no. JE120662H - PJE120706H, PJE620733S - PJE621387S.

Cardiovascular Devices

3

Yes

Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America

Sigma implantable pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker, models SDR203, SDR303, SDR306

Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com.  Model SVDD303: serial no. PJD183400H - PJD183447H, PJD186130H - PJD186199H, PJD188418H - PJD188519H, PJD430299H - PJD430332H, PJD441378H - PJD441396H, PJD442436H - PJD442448H, PJD445371H - PJD448139H, PJD675113S - PJD675193S, PJD675694S - PJD676809S, PJD677182S - PJD677945S, PJD678157S - PJD686906S, PJD730001S - PJD744349S.

Cardiovascular Devices

3

Yes

Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America

Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacing Pacemaker. Atrial Bipolar sensing connector, ventricular Bipolar connector, model SVDD303.

Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com.  Model SS103: serial no. PJG160592H - PJG161247H, PJG162149H - PJG162607H, PJG163245H - PJG163805H, PJG165759H - PJG168541H, PJG170637H - PJG170921H, PJG428851H - PJG431485H, PJG677154S - PJG748119S, PJG748671S - PJG748710S, PJG748732S - PJG750863S, PJG751336S - PJG751944S, PJG752070S - PJG754744S, PJG231054M - PJG233721M, PJG748407C - PJG748670C, PJG748711C - PJG748722C. Model SS106: serial no. PJH117098H - PJH118839H, PJH624138S - PJH624610S, PJH626910S - PJH626967S. Model SS203: serial no. PJG165866H, PJG170641H - PJG170782H, PJG428850H - PJG431464H, PJG676637S - PJG681858S, PJG682490S, PJG683196S, PJG684296S - PJG689861S, PJG695412S, PJG747908S - PJG754745S, PJG231551M - PJG234346M. Model SS303: serial no. PJG162131H - PJG16371H, PJG427797H - PJG431510H, PJG676969S - PJG691865, PJG740396S - PJG757886S.

Cardiovascular Devices

3

Yes

Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America

Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS303

Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com.  Model SVVI103: serial no.PJG159902H - PJG176701H, PJG432779H - PJG432895H, PJG230582M - PJG236398M, PJG677442S - PJG696014S, PJG748310S - PJG755468S, PJG747654C - PJG755171C.

Cardiovascular Devices

3

Yes

Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America

Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for ventricular use only.