Z-1222-2011

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

Name: Z-1222-2011 Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071, Manufactured by Maquet...
Creator: Maquet Cardiovascular
Published: 2010-06-04
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2010-06-04 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular began a recall of Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071, Manufactured by Maquet Cardiovascular, Wayne, New Jersey. Intended for use... on 2010-06-04. The reason FDA records is "Pouch integrity may be compromised, resulting in loss of sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1222-2011
Status: Terminated
Initiated: 2010-06-04
Posted: 2011-02-11
Terminated: 2011-06-21
Recalling firm: Maquet Cardiovascular LLC
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.
Product code: FZT Cutter, Surgical
Reason for recall: Pouch integrity may be compromised, resulting in loss of sterility.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot numbers 9081071 and 9082071.

Product code FZT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)