Medtronic HMS PLUS, Hemostasis Management System, Model… recallZ-1070-2010 · Medtronic Inc · initiated Dec 14, 2009
Terminated All recalls posted in March 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Recently the US Food and Drug Administration (FDA) issued an alert, communicating a change in the United States Pharmacopeia (USP) monograph for heparin, introducing a new USP reference standard that will in effect, change potency, and harmonize the USP unit dose with the WHO International Standard (IU) unit dose. Users of the Medtronic Hemostasis Management System (HMS Plus) must be aware o
FDA root cause category: Other
What the company is doing
Consignees were sent a Medtronic "Urgent Medical Device Notice' dated December 14, 2009. The letter was addressed to "Valued Customer". The letter described the product and the problem. Advised customers to configure the HMS Plus appropriately. The Field Notification was sent to all current HMS Plus users. The current HMS Plus users were identified by the sales of HMS Plus disposable product -Heparin Assay Cartridges from the period of August 1, 2008 to date. This time was considered appropriate, being more than twice the longest expiration date of any of the HMS disposable.
Recall details
- Recall number
- Z-1070-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 14, 2009
- Posted by the FDA
- Mar 11, 2010
- Recalling firm
- Medtronic Inc
- Quantity
- 580
- Product code
- JOX
- FDA submissions
- K894317
- Distribution
- All states in USA (Including DC) except RI and VT.
Product description
Medtronic HMS PLUS, Hemostasis Management System, Model 30514. It is 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.
Code information (models, lots, serial numbers)
Catalogue Number 30514
Other devices under the same FDA submission
1 device cleared under K894317 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- HMS PLUS 30514Medtronic, Inc. · ANALYZER, HEPARIN, AUTOMATED71 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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