Sorin Orchestra Programmer Overestimates Pacemaker Battery Life
Sorin Group Italia is notifying physicians that its Orchestra programmer may overestimate the residual longevity of specific implanted pacemakers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a software error could lead to delayed replacement of a pacemaker, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Sorin Group Italia S.r.l. has voluntarily issued a notification to physicians regarding the ORCHESTRA and ORCHESTRA PLUS programmers. The notification addresses a potential overestimation of the residual longevity displayed by the programmer during follow-up exams for patients implanted with specific pacemaker models.
The affected pacemaker models include REPLY (Models D, DR, VDR, SR), ESPRIT (Models D, DR, S, SR), and FACIL (Model DR1). The recall covers 1,718 units of the programmer, which were distributed nationwide.
Physicians are advised to review the longevity data for patients implanted with these specific pacemaker models to ensure accurate monitoring of device status.
The recalled product
- Product
- ORCHESTRA/ORCHESTRA PLUS Programmer
- Manufacturer
- Sorin Group Italia S.r.l.
- Affected units
- 1,718
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- DR
- VDR
- SR - ESPRIT Models D
- S
- SR - FACIL Model DR1
Distribution
Distributed nationwide across the United States.
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