Sorin Perceval Sutureless Aortic Heart Valve Field Action
Sorin Group USA is conducting a voluntary field action for Perceval Sutureless Aortic Heart Valves due to updated implantation procedure steps.
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 a voluntary field action due to updated procedure steps without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Sorin Group USA, Inc. has announced a voluntary field action for the Perceval Sutureless Aortic Heart Valve. The affected products include sizes S, M, L, and XL, with item numbers ICV1208, ICV1209, ICV1210, and ICV1211, and reference numbers PVS21, PVS23, PVS25, and PVS27. The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
The field action is being conducted due to updated steps associated with the implantation procedure. The source text does not specify the exact nature of the updated steps or any reported injuries or illnesses. The agency classification for this recall is Class II.
A total of 845 units are affected by this action. The distribution pattern is worldwide, including nationwide distribution in the United States and in numerous other countries such as Canada, the United Kingdom, Germany, France, and Australia. The source text does not specify a specific lot number, stating "All Lots" in the structured data, but the raw text does not explicitly confirm this scope beyond the general field action announcement.
Consumers and healthcare providers should contact Sorin Group USA, Inc. for further information regarding this field action and the updated implantation procedure steps.
The recalled product
- Product
- Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item #…
- Manufacturer
- Sorin Group USA, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 845
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 (1)
- All Lots
Distribution
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 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
Similar recalls
- ModerateSorin Dual Stage Venous Return Catheter Recalled for Incorrect Instructions
FDA (Devices) · 2016-02-24
- HighSorin S5 Heart-Lung Machine Recalled for Power Supply Failure Risk
FDA (Devices) · 2016-09-28
- ModerateSorin Group Recalls CDI H/S Cuvettes Due to Connection Error
FDA (Devices) · 2016-03-02
- HighLivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure
FDA (Devices) · 2020-09-30
- SevereSorin S5 Perfusion System Recalled for Motor Controller Faults
FDA (Devices) · 2012-11-14
- SevereSorin C5 Perfusion System Recalled for Motor Controller Fault
FDA (Devices) · 2012-11-14