Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071, Manufactured by Maquet Cardiovascular

FDA device recall Z-1222-2011 · posted 2011-02-11 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular

Reason for recall

Pouch integrity may be compromised, resulting in loss of sterility.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

FZT

Quantity affected

395 units

Distribution

Worldwide Distribution -- USA, including states of IA, KY, IL, WI, TX and NC and countries of Japan, Germany and Hong Kong.

Date initiated

2010-06-04

Date posted

2011-02-11

Date terminated

2011-06-21

Location

San Jose, CA