| Class 2 Device Recall HEARTSTRING Aortic Cutter 4.3 mm | |
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 |
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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.
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