PTA BALLOON CATHETER MARKET ANALYSIS

Market Challenges And Opportunities

• Increasing number of product recall by the U.S. FDA (Food and Drug Administration)

Global PTA Balloon Catheter Market: Restraint

PTA balloon catheters are regulated by the U.S. Food and Drug Administration in the U.S. The Food and Drug Administration (FDA), the U.S. agency responsible for medical device regulation, issues guidance dedicated to requirements for certain Class II applications. Hence, product recall by U.S. FDA is expected to hamper the market growth.

For instance, in October 2020, the U.S. Food and Administration recalled Class 2 device conquest PTA balloon dilatation catheter offered by Bard Peripheral Vascular Inc., a manufacturer of medical equipments. The product was recalled due to packing issue. The labelling states that the balloon size is 6mm x 40mm, however included a 5mm x 40mm balloon. Dilation catheter was packaged with the wrong size balloon.

In June 2019, Cook Medical’s, a medical device company, product balloon catheter used for percutaneous transluminal angioplasty was recalled by the U.S. FDA. MedWatch, the Food and Drug Administration’s “Safety Information and Adverse Event Reporting Program, reported complaints such as the surgery may be delayed if the balloon burst below the rated burst pressure, requiring another intervention.