The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Vascular Solutions, Inc. Langston Dual Lumen Catheter
- Lot Numbers: Lots distributed between July 12, 2019 and March 10, 2020
- Model Number: Model 6F 5540
- Manufacturing Dates: June 22, 2019 to December 02, 2019
- Distribution Dates: July 12, 2019 to March 10, 2020
- Devices Recalled in the U.S.: 4,304
- Date Initiated by Firm: March 16, 2020
The Vascular Solutions, Inc. Langston Dual Lumen Catheter is used for the rapid delivery of dye (contrast material) into a patient’s blood vessels during medical imaging tests (angiographic studies) to allow clinicians to see internal body structures. The device also measures pressure within the blood vessel.
Reason for Recall
Vascular Solutions, Inc. is recalling the Langston Dual Lumen Catheter because there is a potential the inner catheter may separate during use. If the inner catheter separates, it could cause serious health conditions including additional surgical procedures to remove the separated section, damage to the blood vessel or death. If the inner catheter separates outside of the patient’s body, the dye could spray the doctor and lead to an infection that may require the doctor to receive treatment.
There have been 8 complaints and no reports of injury or death.
Who May be Affected
- Health care providers using the Langston Dual Lumen Catheter
- Patients undergoing angiography procedures using the Langston Dual Lumen Catheter
What to Do
From March 26-31, 2020, Vascular Solutions, Inc. contacted their customers by mail or email informing them of the affected device, model, and lot numbers and provided the following instructions:
- Secure and remove all unused affected devices
- Complete the Recall Acknowledgement Form
Teleflex (Vascular Solutions, Inc.’s parent company) will destroy any unused recalled devices.
Customers who have questions about the notice should contact Vascular Solutions 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.
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How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.