FDA Medical Device Recalls (openFDA)
Guidant Corp-Cpi Division: Discovery II Multiprogrammable Pacemaker, Model 1184
- Recall number
- Z-1013-03
- Recalling firm
- Guidant Corp-Cpi Division
- Product
- Discovery II Multiprogrammable Pacemaker, Model 1184
- Status
- Terminated
- Initiated
- 2003-06-23
- Posted
- 2003-07-15
- Terminated
- 2004-07-02
- Reason
- Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
- Root cause
- Other
- Action
- On June 23, 2003, sales representatives began retrieving any recalled pacemakers, which were not implanted. For implanted pacemakers, an 'Important Patient Management Information' letter, dated June 23, 2003, was sent to physicians recommending that pacemaker-dependent patients, with the potentially affected pacemakers, be scheduled for exams to check for proper pacemaker performance using a programmer.
- Quantity
- 15 pacemakers
- Distribution
- Nationwide in the United States and worldwide.
- Lot, serial or model codes
- Serial numbers 319492, 319493, 319494, 319495, 319496, 319497, 319498, 319499, 319500, 319501, 319502, 319503, 319505, 319506, and 319507
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DXY
- Firm FEI
- 2124215
- Firm city
- St Paul
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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