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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns SoftFlow Aortic Cannula

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  Class 2 Device Recall Sarns SoftFlow Aortic Cannula see related information
Date Initiated by Firm February 23, 2012
Date Posted March 23, 2012
Recall Status1 Terminated 3 on April 03, 2013
Recall Number Z-1292-2012
Recall Event ID 60718
510(K)Number K934127  K083301  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 8.0mm (24Fr) OD with 3/8" connector, 8.75" (22cm) long

Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.
Code Information catalog number: 144979 and lot numbers: 0626594 and 0642408
Recalling Firm/
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact Tracy Bellanca
Manufacturer Reason
for Recall
During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Terumo sent an URGENT MEDICAL DEVICE RECALL letter dated February 23, 2012 via Federal Express to all US customers. Terumo Foreign Affiliates received the recall notification via email on February 24th, 2012. The letters identified the affected products, reson for removal, potential hazard, affected population and actions to be taken. Customers were instructed to review the Medical Device Removal notice, assure that all users are aware of the notice, confirm receipt of this communication by faxing the attached Customer Response Form to the fax number provided or email to tcvs.recall@terumomedical.com and call Terumo CVS Customer Service for a Returned Goods Authorization (RGA) number. For questions call Terumo CVS Customer Service at 1-800-521-2818.
Quantity in Commerce 188,282 Cannulae and 248 Custom Tubing Packs
Distribution USA Nationwide Distribution including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of: CANADA, CHILE, India, Japan, Singapore, AUSTRALIA, Malaysia, BELGIUM, BELGIUM, BRAZIL, CHILE, BRAZIL, BRAZIL, and Philippines.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = 3M HEALTH CARE, SARNS
510(K)s with Product Code = DWF and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.