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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheters. After an internal investigation, VSI…"
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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