The Recall Desk
ModerateFDA (Devices)·Z-0716-2017·Announced 2016-12-14

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.

What this means for you

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 # ICV
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

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Related recalls

Same manufacturer · Sorin Group USA, Inc.

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