United States FDA announced that Vascular Solutions, Inc. is recalling Langston Dual Lumen Catheter, (a class I medical device) due to risk of separation during use

During angiographic studies (Medical imaging tests), this Langston Dual Lumen Catheter is utilized for the rapid delivery of contrast agents (dye materials) into the patient blood vessels. This will allow clinicians to examine the internal body structures. It also measures pressure within the blood vessel.

Recall reason:

FDA received 8 device adverse incident reports (complaints) pertaining to this class I medical device and no reports of injury or death were received.

Device Incident: Potential of inner catheter separation 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 on the doctor and could lead to an infection which might require doctor to receive treatment.

A total of 4,304 catheters (Langston Dual Lumen Catheter; model number: Model 6F 5540) were involved in this recall which were manufactured from 22-Jun-2019 to 02-Dec-2019 and distributed in the United States between 12-Jul-2019 to 10-Mar-2020.

On 16-Mar-2020, Vascular Solutions, Inc initiated the recall of this medical device product by contacting their customers by mail and email and informing them of the affected device, model, lot numbers and provided the following instructions:

1. To secure and remove all unused affected devices
2. to complete the recall acknowledgement form

Also, the company would be destroying the unused recalled device products

Voluntary Reporting:

Medical Device Class I Recall is a serious type of recall, as these class of products enter the market without prior robust clinical evaluation pertaining to safety and efficacy. The major channel of gaining the knowledge on product safety is through voluntary reporting of safety concerns from public to the regulatory bodies. Health care professionals and consumers are advised to report any medical device adverse incident reports or injuries to the USFDA by online voluntary reporting facility through MedWatch online reporting. This will facilitates accumulation of the more evident safety data which could expedite the regulatory actions by FDA.