Sorin Coronary Artery Perfusion Cannula Recalled for Tip Angle Defect
Sorin Group USA is recalling 1,205 units of Coronary Artery Perfusion Cannulas with Balloons because the tip angle is less than the required 45 or 90 degrees.
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 classified as FDA Class II, and the defect is a dimensional deviation (tip angle) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Sorin Group USA, Inc. is recalling 1,205 units of the Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The recall is due to a manufacturing defect where the tip of the cannula is bent at an angle less than the required 45 or 90 degrees. Samples returned to the manufacturer confirmed that the tip angle did not meet specifications.
The affected devices are distributed worldwide, including in the United States (Illinois, Missouri, Texas), Canada, and Italy. The specific lot numbers involved are 1425900137, 1433900079, 1433900080, and 1435300088. These devices are intended to come into direct contact with the central circulatory system to receive infused cardioplegia solution.
Healthcare providers and facilities should stop using the affected lots and contact Sorin Group USA, Inc. for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff
- Manufacturer
- Sorin Group USA, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 1,205
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 (4)
- Lot Numbers: 1425900137
- 1433900079
- 1433900080
- 1435300088.
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.
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