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.
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 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…
- 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) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighSorin Recalls Aortic Arch Cannulae Due to Incorrect Tip Angle
FDA (Devices) · 2016-07-20
- HighSorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip
FDA (Devices) · 2017-08-16
- HighSorin FlexFlow Venous Cannula Recalled for Sharpness Defect
FDA (Devices) · 2017-11-15
- ModerateTerumo Recalls Sarns Aortic Arch Cannulas Due to Loose Fiber Particulate
FDA (Devices) · 2014-07-30
- HighTerumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect
FDA (Devices) · 2012-12-12
- HighTerumo Recalls Sarns Soft-arc Aortic Cannula Due to Loose Fiber Particulate
FDA (Devices) · 2014-07-30