Teleflex’s (TFX) Vascular Solutions, Inc. Issues Recall of Venture® Catheters
- Company Announcement Date:
- June 22, 2017
- FDA Publish Date:
- February 09, 2018
- Reason for Announcement:
- Company Name:
- Teleflex Vascular Solutions, Inc.
- Brand Name:
- Product Description:
Vascular Solutions, Inc. voluntarily initiates a worldwide recall of Venture Catheters on April 25, 2017
Teleflex Incorporated (NYSE: TFX), announces a worldwide recall of Venture® Catheters was voluntarily initiated by its Vascular Solutions, Inc. subsidiary on April 25, 2017. Vascular Solutions, Inc. is the manufacturer of Venture Catheters, which are designed for use in catheterization procedures, to direct, steer, control, and support a guidewire to access discrete regions of the coronary and peripheral vasculature. Two versions may also be used for manual delivery of saline solution or diagnostic contrast agents.
The U.S. Food and Drug Administration (FDA) classified this as a Class I recall. The FDA defines Class I recall as, "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."
The worldwide recall affects 4,679 units distributed in the United States. All unexpired lots of the Rapid Exchange (RX), Over-the-Wire (OTW), and Coronary Sinus (CS) versions of the product have been recalled due to the potential for excess material to be present within the inner lumen of the distal catheter tip. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury. No serious injuries or death have been reported in association with this issue to date.
Vascular Solutions, Inc. initiated the recall through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. Healthcare facilities with affected Venture Catheters should remove the products from their inventory and return them to Vascular Solutions, Inc. The notification identified the specific unexpired lots subject to the recall and included instructions on how to return the affected products to Vascular Solutions, Inc.
Vascular Solutions, Inc. has notified the FDA of this action.
Vascular Solutions, Inc. Venture Catheters Affected Product Codes and Lots.
Consumers with questions may contact the company by phone at 1-888-240-6001 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time or by email at firstname.lastname@example.org.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178