Z-0076-2018Class II

FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile...

Name: Z-0076-2018 FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile...
Creator: Sorin Group USA, Inc.
Published: 2017-09-28
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2017-09-28 / Terminated

FDA source

Sorin Group USA, Inc. began a recall of 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... on 2017-09-28. FDA classified it as Class II and gives the reason as "A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0076-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-28
Posted: 2017-11-08
Terminated: 2018-10-17
Recalling firm: LivaNova USA, Inc.
Product: 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 code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
FDA root cause: Process change control
Action: LivaNova sent an Urgent Medical Device Recall letter dated September 28 2017, to all affected consignees. The letter instructed customer to isolate products belonging to the lot involved. The level of the effectiveness check is Level A, where 100% of the consignees will be contacted. The customers were requested to send back any affected product and to complete the attached Customer Response Form by fax to 303-467-6502 or by email to [email protected]. For questions customers were advised to contact Customer Service at 800-.650-2623.
Quantity in commerce: 40 units
Distribution: Worldwide Distribution - US (nationwide) Internationally to France and Spain
Product codes and lots: Lot: 181185; UDI: (01)10803622125812(240)200-200(17)200703(10)181185

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0076-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0076-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-08

Product code DWF

K052081Class IIRemote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc. / cleared 2005-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)