Sorin Orchestra Programmer Recalled for Inaccurate Longevity Estimates
Sorin Group USA is voluntarily recalling 847 Orchestra and Orchestra Plus programmers because residual longevity estimates may be inaccurate.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is a voluntary field action addressing a potential inaccuracy in longevity estimates without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Sorin Group USA, Inc. has announced a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer. The recall involves 847 units of these portable devices, which are equipped with microprocessors used to program and interrogate Sorin implantable pacemakers and defibrillators.
The reason for the field action is that the residual longevity estimate provided by the devices may be less accurate. These programmers also provide measurement, ECG display, and report printing functions that are essential for monitoring implant patients.
The affected programmers were distributed nationwide to VA/government/military facilities, Canadian consignees, and other foreign consignees. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring…
- Manufacturer
- Sorin Group USA, Inc.
- Hazard
- Affected units
- 847
Distribution
Part of a larger recall action
This product is one of 2 recalled by Sorin Group USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Sorin Group USA, Inc.
See all →- HighSorin FlexFlow Venous Cannula Recalled for Sharpness Defect
FDA (Devices) · 2017-11-15
- HighSorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip
FDA (Devices) · 2017-08-16
- HighLivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
Same hazard · inaccurate data
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighPhilips Recalls Cardiac Workstation 5000 Units for Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26
- HighPhilips Recalls Cardiac Workstation 7000 Due to Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26
- HighICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issues
FDA (Devices) · 2020-05-06
- ModerateRandox Chemistry QC Premium Plus Recalled for Incorrect Sodium Values
FDA (Devices) · 2020-04-01
Similar recalls
- HighSorin Orchestra Programmer Overestimates Pacemaker Battery Life
FDA (Devices) · 2014-01-29
- ModerateMedtronic CareLink Encore Programmer Recall for Inaccurate Longevity Estimates
FDA (Devices) · 2019-11-06
- ModerateMedtronic 2090 CareLink Programmer Recall for Inaccurate Longevity Estimates
FDA (Devices) · 2019-11-06
- HighBoston Scientific ZOOM LATITUDE Programmer Software Anomaly Recall
FDA (Devices) · 2022-09-07
- ModerateMedtronic CareLink SmartSync Device Manager Recall for Inaccurate Longevity Estimates
FDA (Devices) · 2019-11-06
- SevereSorin Platinium CRT-D Recall Due to Pacing and Sensing Loss
FDA (Devices) · 2018-08-22