FDA Medical Device Recalls (openFDA)
Medtronic Inc. Cardiac Rhythm Disease Managment: 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.
- Recall number
- Z-1537-2010
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Managment
- 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.
- Status
- Terminated
- Initiated
- 2010-03-08
- Posted
- 2010-05-04
- Terminated
- 2011-12-31
- Reason
- The heparin assay controls may run longer than normal and in some cases, fail to give an acceptable result.
- 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
- 508 US, 36 OUS
- Distribution
- Worldwide Distribution -- United States, International West (countries included in Western Europe and the Middle East), Australia and Canada.
- Lot, serial or model codes
- HMS Plus Catalog Number: 30514; Heparin Assay Controls: 306-01POR, 306-02POR, 306-03POR, 306-04POR, 306-05POR and 306-09POR.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JPA
- Firm FEI
- 2182208
- Firm city
- Saint Paul
- Firm state
- MN
- 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