Facility

ACIST MEDICAL SYSTEMS, INC.

3 recall(s) on record — most severe on record: Class I.

Key facts

3recalls · worst Class I

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3001726808
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	7905 FULLER ROAD EDEN PRAIRIE, MN, US 55344
Registration status	Active · expires 2026
Parent company	ACIST MEDICAL SYSTEMS, INC. (owner-operator 9028115)
Brand names	A2000 Multi-use Syringe Kit, A2000V Multi-use Syringe Kit, B/BT2000 Automated Manifold Kit

Activity by year

Recalls (3)
Inspections (3)

Devices registered here (1)

Injector And Syringe, Angiographic
Product code DXT (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1650

Recalls & enforcement

Class ITerminated2021-01-22
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 fail…
Class IITerminated2015-12-21
Reports related to ingress of air into the manifold.
Class IITerminated2013-03-15
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…

FDA inspections (3)

NAI2022-02-28
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2019-03-04
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
NAI2016-03-01
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by ACIST MEDICAL SYSTEMS, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ACIST MEDICAL SYSTEMS, INC. (FEI 3001726808) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001726808-acist-medical-systems-inc/

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