Medtronic Inc. Cardiac Rhythm Managment Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303
Brand
Medtronic Inc. Cardiac Rhythm Managment
Lot Codes / Batch Numbers
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.
Products Sold
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.
Medtronic Inc. Cardiac Rhythm Managment is recalling Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303 due to An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. There have been no reported patient injuries or deaths due to this issue.
Recommended Action
Per FDA guidance
Press Release was issued 11/29/05. Hospital/physician letters sent via registered mail on 11/29/05 for delivery on 12/01/05. Unimplanted devices are being retrieved. The Physician letter describes the issue, root cause, the probability of reoccurrence and provides recommendations. A list of affected serial numbers that the physician is following or has implanted is attached to the letter. The letter also provides medtronic's website in which regular updates on the ongoing actual performance are listed in their Product Performance Report. Medtronic is providing a replacement device should the Physician and patient elect to replace the affected implanted device.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026