Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ORCHESTRA/ORCHESTRA PLUS Programmer Recalled by Sorin Group Italia S.r.l. Due to Sorin has voluntarily issued a notification to physicians...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sorin Group Italia S.r.l. directly.
Affected Products
ORCHESTRA/ORCHESTRA PLUS Programmer
Quantity: 1,718
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sorin Group Italia S.r.l.
Sorin Group Italia S.r.l. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report