Sorin Group USA, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2757-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tube for purposes of receiving the infused cardioplegia solution. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.

Product Classification:

Class II

Date Initiated: August 12, 2016

Date Posted: September 14, 2016

Recall Number: Z-2757-2016

Event ID: 74934

Reason for Recall:

The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.

Status: Terminated

Product Quantity: 1205 units worldwide

Code Information:

Lot Numbers: 1425900137, 1433900079, 1433900080, 1435300088.

Distribution Pattern:

Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.

Voluntary or Mandated:

Voluntary: Firm initiated