Events

Recall of Sarns" SoftFlow Aortic Cannula without Suture Flange

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66624
  • Event Risk Class
    Class 2
  • Event Number
    Z-0193-2014
  • Event Initiated Date
    2013-10-23
  • Event Date Posted
    2013-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122796
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Reason
    During an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of sarns" soft-flow¿ aortic cannulae and sarns" venous return cannulae.
  • Action
    On 10/23/13, Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE RECALL LETTER to their consignees. The letter identified the reason for the device removal, identified the affected product and associated potential hazards, and provided recall instructions to their customers regarding affected product return. Questions regarding this recall are directed to CVS Customer Service M-F, 8am-6pm at 1-800-521-2818.

Device

Sarns" SoftFlow Aortic Cannula without Suture Flange
  • Model / Serial
    Catalog Number 5762 Lot Numbers 0677300
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.
  • Product Description
    Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. || Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA