FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular: 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.
- Recall number
- Z-1222-2011
- Recalling firm
- Maquet Cardiovascular
- 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.
- Status
- Terminated
- Initiated
- 2010-06-04
- Posted
- 2011-02-11
- Terminated
- 2011-06-21
- Reason
- Pouch integrity may be compromised, resulting in loss of sterility.
- 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
- 395 units
- Distribution
- Worldwide Distribution -- USA, including states of IA, KY, IL, WI, TX and NC and countries of Japan, Germany and Hong Kong.
- Lot, serial or model codes
- Lot numbers 9081071 and 9082071.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FZT
- Firm FEI
- 3000719698
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28