FDA Medical Device Recalls (openFDA)
Medtronic Inc. Cardiac Rhythm Managment: Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS303
- Recall number
- Z-0537-06
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Managment
- Product
- Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS303
- Status
- Terminated
- Initiated
- 2005-11-29
- Posted
- 2006-02-18
- Terminated
- 2007-01-04
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 7,297
- Distribution
- Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- ["P980035S002"]
- Product code
- DXY
- Firm FEI
- 2182208
- Firm city
- Fridley
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28