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 HEARTSTRING Aortic Cutter 4.3 mm

  • 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 HEARTSTRING Aortic Cutter 4.3 mm see related information
Date Initiated by Firm June 04, 2010
Date Posted February 11, 2011
Recall Status1 Terminated 3 on June 21, 2011
Recall Number Z-1222-2011
Recall Event ID 56860
Product Classification Surgical Cutter - Product Code FZT
Product Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071, Manufactured by Maquet Cardiovascular, Wayne, New Jersey.

Intended for use by cardiac surgeons during CABG procedures to create an opening in the wall of a vessel.
Code Information Lot numbers 9081071 and 9082071.
Recalling Firm/
Manufacturer		 Maquet Cardiovascular
170 Baytech Dr
San Jose CA 95134-2302
For Additional Information Contact Nitya Narayanan
408-635-0553
Manufacturer Reason
for Recall		 Pouch integrity may be compromised, resulting in loss of sterility.
FDA Determined
Cause 2		 Process control
Action Urgent Device Removal letters were sent out on June 10, 2020 by Federal Express. The letter identified the affected product, described the reason for the recall, and asked for all affected product to be returned. The firm asked customers to examine their inventory and to discontinue distributing the affected lots. In addition, customers are to complete and return the Field Action Response form. If the affected product was further distributed, those customers also need to be notified of the recall and return their affected product to their distributor. All affected returned products may be exchanged with other unaffected HEARTSTRING Aortic Cutter 4.3 MM devices. Customers are to contact their local MAQUET Cardiovascular sales representative or Customer Service at 1-888-880-2874 to arrange for an exchange and if they have any questions.
Quantity in Commerce 395 units
Distribution Worldwide Distribution -- USA, including states of IA, KY, IL, WI, TX and NC and countries of Japan, Germany and Hong Kong.
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.
-
-