Sorin Group USA, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0076-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced to allow clamping the proximal end that terminates in a 3/8 inch (9.5 mm) barbed connector for standard cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a malleable wire. Each component is packaged inside a protective sheath in a single sterile, sealed pouch

Product Classification:

Class II

Date Initiated: September 28, 2017

Date Posted: November 15, 2017

Recall Number: Z-0076-2018

Event ID: 78331

Reason for Recall:

A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.

Status: Terminated

Product Quantity: 40 units

Code Information:

Lot: 181185; UDI: (01)10803622125812(240)200-200(17)200703(10)181185

Distribution Pattern:

Worldwide Distribution - US (nationwide) Internationally to France and Spain

Voluntary or Mandated:

Voluntary: Firm initiated