Vascular Solutions Recalls Venture Catheters Due to Material Detachment Risk
Vascular Solutions, Inc. is voluntarily recalling Venture RX, OTW, and CS catheters because material may detach from the distal tip during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where material may detach during use, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters from the market. The affected products include the Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheters. These devices are indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW versions may also be used for manual delivery of saline solution or diagnostic contrast agents.
The recall was initiated after an internal investigation determined that material used in the catheter construction may detach from within the lumen of the distal tip during use. This potential problem affects 13,551 units, of which 7,054 are unexpired. The products were distributed worldwide, including nationwide in the United States and in numerous international countries such as Australia, Canada, and the United Kingdom.
Healthcare providers and facilities should stop using the affected catheters and contact Vascular Solutions, Inc. for further instructions on the return or disposal of these devices. Patients who have had these catheters used during a procedure should consult their healthcare provider if they have concerns regarding the potential for material detachment.
The recalled product
- Product
- Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the
- Manufacturer
- Vascular Solutions, Inc.
- Category
- Medical Device — Catheter
- Hazard
Distribution
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