Z-0940-2011

Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ

Name: Z-0940-2011 Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ
Creator: Maquet Cardiovascular, LLC
Published: 2010-05-05
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2010-05-05 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular, LLC began a recall of Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ Intended use: medical device for use by cardiac surgeons... on 2010-05-05. The reason FDA records is "Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate". 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-0940-2011
Status: Terminated
Initiated: 2010-05-05
Posted: 2011-02-01
Terminated: 2011-06-21
Recalling firm: Maquet Cardiovascular LLC
Product: Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
Product code: DXC Clamp, Vascular
Reason for recall: Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm, MAQUET Getinge Group, sent an "URGENT DEVICE REMOVAL IMMEDIATE ACTION REQUIRED" letter dated May 5, 2010, to all customers via Federal Express. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to immediately examine their stocks to determine if they have any of the affected product, if found, discontinue dispensing (distributing) the lot and complete the Field Action Response Form; immediately contact accounts if they acted as a distributor, and acknowledge receipt of this notification whether or not they have any affected products by completing the Field Action Response Form via fax to (U.S.): 1-888-899-2874. If you have any additional questions, please contact your local MAQUET Cardiovascular sales representative or our Customer Service at 1-888-880-2874.
Quantity in commerce: 1630
Distribution: Worldwide distribution: USA and countries including: Japan, Mexico, Germany, Switzerland, Israel
Product codes and lots: Lot numbers 12895788, 12946718, 25002866, 25004647, 13029141, 25005045, 25005622

Product code DXC

K022880Class IIGuidant Proximal Seal System, Models Pss-4500 & Ps-4500Guidant Corp. / cleared 2002-09-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)