Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0076-2018 · Posted None

Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeDWF
Date Initiated2017-09-28
Date Terminated2018-10-17
Product Quantity40 units

Reason for Recall

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

Firm 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.

Root Cause

Process change control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052081REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULAEstech, Inc. · 2005-12-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑