FDA Medical Device Recalls (openFDA)
Acist Medical Systems: ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units)
- Recall number
- Z-0064-04
- Recalling firm
- Acist Medical Systems
- Product
- ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units)
- Status
- Terminated
- Initiated
- 2003-10-02
- Posted
- 2003-10-24
- Terminated
- 2005-11-23
- Reason
- 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.
- Root cause
- Other
- Action
- The consignees were sent letters dated 10/2/03 which requested that the product be returned.
- Quantity
- 7120 kits
- Distribution
- Nationwide in the United States.
- Lot, serial or model codes
- Lot Numbers 0933A and 1003I
- 510(k) numbers
- K984231, K991103
- PMA numbers
- not on file
- Product code
- DXT
- Firm FEI
- 3001726808
- Firm city
- Eden Prairie
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28