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ACIST Medical Systems, Inc.

United States·US-MF-000010784

Last updated September 17, 2026

About

ACIST Medical Systems provides innovative contrast injector & IVUS catheter diagnostic technologies to visualize, assess & improve patient treatment.

From the manufacturer's own website, in their original language. Source

Information

Country: United States
Address: 7905, Fuller Road, Eden Prairie, United States
Website: acist.com/
LinkedIn: linkedin.com/company/acist-medical-systems
Facebook: facebook.com/ACISTMedicalSystemsInc
Email: [email protected]
Phone: +1 612-227-4734
PRRC Contact: Milana Solganik
EUDAMED SRN: US-MF-000010784
FDA FEI Number: 3001726808
DUNS Number: —

Catalogue (274)

Page 1 of 6

Device	Model / Reference	Registries	Class	Status
AngioTouch Module (15')	019312	EUDAMED	Class I	Active
017681	017681	EUDAMED	Class I	Active
ACIST Pro Hemodynamic Cable	019337	EUDAMED	Class I	Active
ACIST Pro Hemodynamic Cable	019336	EUDAMED	Class I	Active
ACIST Pro Accessories	ACIST Pro Hemodynamic Cable	EUDAMED	Class I	Active
CVi® Cable	015634	FDA UDI	Class II	Unknown
CVi® Accessory	015574	FDA UDI	Class II	Active
ACIST HDi® HD IVUS System	017986	FDA UDI	Class II	Unknown
ACIST RXi® Ao Interface Box	018311	FDA UDI	Class II	Active
RXi® Cable	017748	FDA UDI	Class II	Active
RXi® Mini Navvus Interface Cable	018595	FDA UDI	Class II	Active
CVi® Cable	015640	FDA UDI	Class II	Active
ACIST HDi® Patient Interface Module (PIM)	017989	FDA UDI	Class II	Unknown
AngioTouch® Kit	014644	FDA UDI	Class II	Unknown
AngioTouch® Kit	014645	FDA UDI	Class II	Unknown
ACIST RXi® Console, Refurbished	018084	FDA UDI	Class II	Unknown
ACIST CVi® Angiographic Injection System	014658	FDA UDI	Class II	Unknown
A2000 Multi-use Syringe Kit	014612	FDA UDI	Class II	Unknown
Single-use Syringe Kit	016605	FDA UDI	Class II	Unknown
CVi® Cable	015629	FDA UDI	Class II	Active
AngioTouch® Kit	014645	FDA UDI	Class II	Unknown
RXi® Cable	017039	FDA UDI	Class II	Active
CVi® Cable	0146CG	FDA UDI	Class II	Active
ACIST HDi® System Console	017987	FDA UDI	Class II	Unknown
CVi® Cable	015641	FDA UDI	Class II	Unknown
CVi® Cable	015645	FDA UDI	Class II	Active
ACIST CVi® Angiographic Injection System Power Supply	017906	FDA UDI	Class II	Unknown
ACIST HDi® Bed Rail Mount	018196	FDA UDI	Class II	Active
AngioTouch® Kit	014643	FDA UDI	Class II	Unknown
CVi® Cable	015636	FDA UDI	Class II	Unknown
ACIST RXi® Console with dPR	019994	FDA UDI	Class II	Active
ACIST CVi® Angiographic Injection System	014657	FDA UDI	Class II	Unknown
AngioTouch® Kit	014644	FDA UDI	Class II	Unknown
RXi® Mini Navvus Interface Cable	018679	FDA UDI	Class II	Active
RXi® Cable	018365	FDA UDI	Class II	Active
ACIST CVi® Contrast Delivery System Power Supply	016226	FDA UDI	Class II	Active
CVi® Cable	015646	FDA UDI	Class II	Active
RXi® Cable	017681	FDA UDI	Class II	Active
AngioTouch® Kit	014645	FDA UDI	Class II	Unknown
ACIST CVi® Contrast Delivery System Injector Head	016224	FDA UDI	Class II	Active
ACIST HDi® Power Supply	017990	FDA UDI	Class II	Unknown
RXi® Cable	017755	EUDAMEDFDA UDI	Class II	Active
CVi® Cable	015639	FDA UDI	Class II	Unknown
CVi® Accessory	015464	FDA UDI	Class II	Active
RXi® Cable	018588	FDA UDI	Class II	Active
A1000V Single Use Syringe Kit	016605	FDA UDI	Class II	Active
Multi-use Syringe Kit	014113	FDA UDI	Class II	Unknown
ACIST RXi® System with dPR	019995	FDA UDI	Class II	Active
ACIST RXi® Mini System Overpack	018599	FDA UDI	Class II	Active
RXi® Mini Navvus Interface Cable	018596	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

ACIST Europe BV NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 22, 2021	Z-1161-2021	—	terminated	Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence.
Dec 21, 2015	Z-0744-2016	—	terminated	Reports related to ingress of air into the manifold.
Mar 15, 2013	Z-1145-2013	—	terminated	ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed w
May 11, 2009	Z-1872-2009	—	terminated	ACIST Medical Systems initiated a recall due to an increase in the incidence of field reports related to a bulge on the side and/or leaks in the bond of the 2.5 high-pressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the ACIST BT2000 Automated Manifold Kit.
Nov 10, 2008	Z-0643-2009	—	terminated	Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an injection scenario that may result in multiple injections of contract media when one injection was intended.
Jun 6, 2008	Z-2406-2008	—	terminated	Some of the sterile package seals of AT P54 AngioTouch Kit were breached. Breached package seals could compromise product sterility, which could potentially lead to patient infection.
Oct 3, 2007	Z-0359-2008	—	terminated	Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture.
May 19, 2004	Z-1002-04	—	terminated	Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.
Oct 2, 2003	Z-0064-04	—	terminated	Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak.