FDA Medical Device Recalls (openFDA)
Abbott Vascular-Cardiac Therapies dba Guidant Corporation: ACS DUOSTAT Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23244
- Recall number
- Z-0391-2007
- Recalling firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation
- Product
- ACS DUOSTAT Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23244
- Status
- Terminated
- Initiated
- 2006-12-05
- Posted
- 2007-02-01
- Terminated
- 2012-07-24
- Reason
- Specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch
- Root cause
- Other
- Action
- On December 5, 2006, the firm began notifying all affected customers, affiliates and distributors of the recall via letter. The letter advises that the firm has voluntarily recalled specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) due to a potentially incomplete seal in the pouch. The letter advises Abbott Vascular will be replacing all returned product and that appropriate corrective actions will be implemented.
- Quantity
- 137 devices
- Distribution
- Worldwide, including USA, Canada, Germany, Italy, Greece, New Zealand, Netherlands, France, Japan, Spain, and Bulgaria.
- Lot, serial or model codes
- 6090551
- 510(k) numbers
- ["K854261","K861847"]
- PMA numbers
- not on file
- Product code
- DTL
- Firm FEI
- 2024168
- Firm city
- Temecula
- Firm state
- CA
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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