Sorin Aortic Arch Cannula Recalled for Improper Tip Angle
Sorin Group USA is recalling Aortic Arch Cannulas 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 source describes a voluntary field action for a manufacturing defect without reporting any injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Sorin Group USA, Inc. is conducting a voluntary field action for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon (part number NA-55X6). These devices are designed for use in the extracorporeal circuit during cardiopulmonary bypass surgery and come into direct contact with the central circulatory system.
The recall is due to a manufacturing defect where the angle of the cannula tip is less than the required 45 or 90 degrees. Samples returned to the manufacturer confirmed that the tip angle did not meet specifications.
Approximately 200 units were distributed worldwide, including in the United States (Illinois, Missouri, Texas), Canada, and Italy. Affected lot numbers are 1526500032, 1529300026, and 1602600042. Healthcare facilities should contact Sorin Group USA for instructions on returning the devices.
The recalled product
- Product
- Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flex
- Manufacturer
- Sorin Group USA, Inc.
- Hazard
- Affected units
- 200
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 (3)
- Lot Numbers: 1526500032
- 1529300026
- 1602600042.
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 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
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-02
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12
- HighUSTAR II Knee System Hinge Box Trial Recall
FDA (Devices) · 2026-08-12