BT2000 Automated Manifold Kit 014613 (UDI 10841716101974)Recalls & reported problems
Acist Medical Systems, Inc. · Model BT2000 p/n 701671-001 Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe, transducer · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841716101974), received between Aug 29, 2019 and Aug 29, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Alarm System” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Alarm System1
- Gas/Air Leak1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2019Device Alarm System; Gas/Air Leak
AIR ERRORS ON THE MACHINE. WE PULLED THE LOT AND WILL RETURN TO THE MANUFACTURER. THE MACHINE ERRED "AIR BUBBLE DETECTED." THE DEPARTMENT DECIDED TO PULL ALL OF THE INVENTORY WITH THAT LOT NUMBER. THEY HAD MORE THAN ONE PATIENT--CANNOT STATE HOW MANY. THEY HAVE HAD OTHER ISSUES WITH THIS ALARM BUT THE DEVICE HAD RECENTLY RETURNED FROM THE MANUFACTURE FROM REPAIR AND IT ALARMED ON THE NEXT PATIENT IT WAS USED ON. AFTER CONTACTING THE MANUFACTURE THEY CONFIRMED THEY HAD NOT REPLACED THE PART BUT THAT IN THEIR PAPERWORK THEY NOTED THEY WOULD REPLACE IT IF WE HAD THE SAME ERRORS AGAIN. IT WAS SENT TO THE MANUFACTURE FOR REPAIR WITH THAT ERROR. THEY (THE DEVICES) HAVE BEEN RETURNED TO THE MANUFACTURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8944508 ↗
Other Injector And Syringe, Angiographic devices
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- NAMIC 80085007Medline Industries, Inc. · Injector and syringe, angiographic1 recall36 reports
- NA 622510B. Braun Medical Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC85 reports
- NAMIC 80087007Medline Industries, Inc. · Injector and syringe, angiographic1 recall20 reports
- Blue Diamond™ 00884450381168Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC1 recall6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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