Analyzer, Heparin, Automated
Hematology · 21 CFR 864.5680
Recent MDR events
198 adverse event reports on file
- HMS PLUS INSTRUMENTJul 22, 2026DeathPerfusion Systems2184009-2026-01057
- HMS PLUS INSTRUMENTJul 22, 2026InjuryPerfusion Systems2184009-2026-01058
- HMS PLUS INSTRUMENTJul 3, 2026MalfunctionPerfusion Systems2184009-2026-00688
- HMS PLUS INSTRUMENTApr 3, 2026MalfunctionPerfusion Systems2184009-2026-00427
- HMS PLUS INSTRUMENTFeb 5, 2026MalfunctionPerfusion Systems2184009-2026-00209
- HR HMS ACT CARTRIDGEFeb 4, 2026MalfunctionMedtronic Perfusion Systems1718389-2026-00001
- HR HMS ACT CARTRIDGEFeb 4, 2026MalfunctionMedtronic Perfusion Systems1718389-2026-00002
- HR HMS ACT CARTRIDGEFeb 4, 2026MalfunctionMedtronic Perfusion Systems1718389-2026-00003
- HR HMS ACT CARTRIDGEFeb 4, 2026MalfunctionMedtronic Perfusion Systems1718389-2026-00004
- HR HMS ACT CARTRIDGEFeb 4, 2026MalfunctionMedtronic Perfusion Systems1718389-2026-00005
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Medtronic IncTerminatedMar 11, 2010
Medtronic HMS PLUS, Hemostasis Management System, Model 30514.
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
Z-1070-2010 · View FDA record ↗ - Diagnostica Stago, Inc.TerminatedJul 20, 2004
STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfr
Incorrect assay ranges on the assay value insert for Heparin Control 5.
Z-1081-04 · View FDA record ↗
Registered firms
8 firms currently registered for this product code
510(k) clearances
15 clearances for this product code
- Medtronic, Inc.Jun 8, 2011
K111339 · HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
- Medtronic, Inc.Nov 4, 2010
K102953 · HEPARIN DOSE RESPONSE CARTRIDGE
- Medtronic, Inc.Oct 13, 2010
K101271 · HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
- Medtronic Perfusion SystemsMay 24, 2005
K051040 · HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
- Medtronic VascularDec 3, 2004
K043080 · HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
- Medtronic VascularOct 1, 2004
K042070 · HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
- Cardiovascular Diagnostics, Inc.Jan 14, 2000
K993519 · RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
- Medtronic Hemotec, Inc.Jul 21, 1992
K922031 · HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL