Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0805-2014 — ORCHESTRA/ORCHESTRA PLUS Programmer

U.S. FDA — Device Enforcement · Italy · 2013-11-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0805-2014
Date of alert
2013-11-20
Country / jurisdiction
Italy
Risk level
Class II
Risk type
recall
Brand
Sorin Group Italia S.r.l.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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