Acist Medical Systems ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Part Number 700318-002. The ACIST injection system is an angiographic injection system used in interventional cardiology, radiology, and vascular surgical procedures. The ACIST injection system supplies radiopaque contrast media to a catheter at a user-determined variable flow rate and volume which can be instantaneously and continuously varied. Manufactured by: ACIST Medical Syst Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Part Number 700318-002. The ACIST injection system is an angiographic injection system used in interventional cardiology, radiology, and vascular surgical procedures. The ACIST injection system supplies radiopaque contrast media to a catheter at a user-determined variable flow rate and volume which can be instantaneously and continuously varied. Manufactured by: ACIST Medical Syst
Brand
Acist Medical Systems
Lot Codes / Batch Numbers
Not associated with specific serial or lot numbers. Model: CVi Toshiba interface Cable, part number 700318-002.
Products Sold
Not associated with specific serial or lot numbers. Model: CVi Toshiba interface Cable, part number 700318-002.
Acist Medical Systems is recalling ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X- due to Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba In. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
ACIST is distributing an Urgent Medical Device Correction letter, dated November 10, 2008, to affected customers. The letter describes the issue and the scenario when the issue to occur, instructs them to discontinue use of the synchronized mode between the ACIST Angiographic Injection System model CVi and the Toshiba Infinix-i X-ray fluoroscopic system by disconnecting the interface cable immediately. The letter states that ACIST is working with Toshiba to resolve this issue. A response form is asked to be returned either by fax, e-mail or mail. If there are any questions, they should be directed to either ACIST at 952-995-9300 or local Sales Reps or Clinical Applications Specialist.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, FL, NY
Page updated: Jan 10, 2026