Z-1537-2010

Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN...

Name: Z-1537-2010 Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN...
Creator: Medtronic Inc. Cardiac Rhythm Disease Managment
Published: 2010-03-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-03-08 / Terminated

FDA source

Medtronic Inc. Cardiac Rhythm Disease Managment began a recall of Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN 55112. A microprocessor based, multichannel clot... on 2010-03-08. The reason FDA records is "The heparin assay controls may run longer than normal and in some cases, fail to give an acceptable result". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1537-2010
Status: Terminated
Initiated: 2010-03-08
Posted: 2010-05-04
Terminated: 2011-12-31
Recalling firm: Medtronic, Inc.
Product: Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN 55112. A microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: The heparin assay controls may run longer than normal and in some cases, fail to give an acceptable result.
FDA root cause: Process change control
Action: Medtronic issued an "Urgent Medical Device Notification" letter dated March 8, 2010 addressed to "Dear Valued Customer" and was sent to three locations at each customer site: Risk Management, Cardiovascular Surgery and Clinical Laboratory-Point of Care. The letter described the product and the issue, provided instructions for control and patient testing. The customer was requested to return an enclosed certificate as proof of notification. For further information, contact your Medtronic Sales Representative or call 1-763-391-9915.
Quantity in commerce: 508 US, 36 OUS
Distribution: Worldwide Distribution -- United States, International West (countries included in Western Europe and the Middle East), Australia and Canada.
Product codes and lots: HMS Plus Catalog Number: 30514; Heparin Assay Controls: 306-01POR, 306-02POR, 306-03POR, 306-04POR, 306-05POR and 306-09POR.

Product code JPA

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