Home › MEDTRONIC, INC. › CLOTtrac™

CLOTtrac™

MEDTRONIC, INC. · Model 550-07 · UDI-DI 00763000558192

JBP

510(k) clearances

321

Adverse events (10 deaths)

Recalls

Facilities

Description

CONTROL 550-07 CLOTTRAC HR 15BX

Recalls

Date	Firm	Reason
2025-11-05	Accriva Diagnostics, Inc.	Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to ha
2025-10-20	Medtronic Perfusion Systems	Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
2010-12-03	Abbott Point Of Care Inc.	Celite ACT cartridges have increased numbers of values outside the accepted allowable error.
2010-10-06	Abbott Point Of Care Inc.	Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.
2010-10-06	Abbott Point Of Care Inc.	Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.
2009-08-18	Abbott Point of Care Inc.	Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. Th
2009-08-18	Abbott Point of Care Inc.	Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. Th
2009-05-05	International Technidyne Corp.	One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.
2005-04-27	International Technidyne Corp.	Validation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Donor Blood as media.
2005-03-16	Abbott Laboratories	Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.