Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall TandemHeart Transseptal CannulasEF set (THTCEF) Dilator assembly

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall TandemHeart Transseptal CannulasEF set (THTCEF) Dilator assembly see related information
Date Initiated by Firm December 02, 2010
Date Posted January 10, 2011
Recall Status1 Terminated 3 on December 01, 2011
Recall Number Z-0889-2011
Recall Event ID 57414
510(K)Number K052570  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly
The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.
Code Information Part number 5140-6221 - Lot numbers 2010060684 & 2010071887
Recalling Firm/
Manufacturer		 Cardiac Assist, Inc
240 Alpha Dr
Pittsburgh PA 15238-2906
For Additional Information Contact Andy Bishop
412-963-7770 Ext. 271
Manufacturer Reason
for Recall		 Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications
FDA Determined
Cause 2		 Other
Action CardiacAssist, Inc. sent a Voluntary Recall letter dated November 12, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to examine inventory for the affected product and remove from inventory and identify it as a recalled product by applying the enclosed "CAUTION: DO NOT USE" sticker(s) and quarantine to prevent usage. Consignees were to complete the form included with the letter and fax a copy of the form to (412) 963-9739 to coordinate the return and replacement of any affected product. For questions regarding this recall call (412) 963-7770, ext. 271.
Quantity in Commerce 164
Distribution Nationwide distribution including AZ, CA, CO, CT, DC, FL, GA, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.
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 = CARDIAC ASSIST, INC.
-
-