FDA Medical Device Recalls (openFDA)
Sorin Group Italia S.r.l.: ORCHESTRA/ORCHESTRA PLUS Programmer
- Recall number
- Z-0805-2014
- Recalling firm
- Sorin Group Italia S.r.l.
- Product
- ORCHESTRA/ORCHESTRA PLUS Programmer
- Status
- Terminated
- Initiated
- 2013-11-20
- Posted
- 2014-01-22
- Terminated
- 2014-09-08
- Reason
- Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker.
- Root cause
- Software design
- Action
- On Nov 20 and Nov 25, 2013, the Dear Doctor Letter was sent by certified mail to 1,310 physicians who are following 13,003 patients implanted with a REPLU or ESPRIT pacemakers in the US. Sorin provided the following recommendations to the physicians: You should consider checking the battery impedance of the last follow-up exam. In case the battery impedance is greater than or equal to 3.5k, a follow-up visit must be scheduled within a maximum of 6 months from the last follow-up visit. When pacemaker operation is checked by the simple application of a magnet, a magnet rate less than 95 min-1 should trigger a follow-up exam in the pacemaker centre. As a general rule, a maximum of 6 month follow-up interval when the battery impedance becomes greater than or equal to 3.5 k. This recommendation should also be followed subsequent to the installation of the new programmer software version.
- Quantity
- 1,718
- Distribution
- Nationwide.
- Lot, serial or model codes
- ORCHESTRA/ORCHESTRA PLUS Programmer implanted with the following pacemaker models. - REPLY Models D, DR, VDR, SR - ESPRIT Models D, DR, S, SR - FACIL Model DR1
- 510(k) numbers
- not on file
- PMA numbers
- ["P950029S041","P980049S050","P060027S011","P980049S006"]
- Product code
- LNX
- Firm FEI
- 1000165971
- Firm city
- Saluggia VC
- Firm state
- not on file
- Firm country
- Italy
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