The company is recalling all lots of the product after it identified potential for damage to the Pascal guide sheath’s inner line due to a manufacturing issue. Edwards found that the issue has occurred in 0.5% of units.
No injuries or patient adverse events were reported in relation to the issue, but Edwards said in an urgent field safety notice that damage to the guide sheath’s inner line could result in embolization of a segment of the inner line material. However, the company added that there is no information suggesting that previously implanted patients could be affected.
Edwards suggested that users of the devices don’t use current inventory of Pascal guide sheaths and return them to Edwards, which will assist with product return and replacement. The guide sheath is the only product affected by the recall, not the entire Pascal transcatheter system.
Customers are urged to review the safety notice, but Edwards said no patient follow-up is necessary. The company added that it notified the relevant regulatory authorities.
The Pascal system is designed to reduce mitral regurgitation while maintaining native anatomy and features contoured, broad paddles to maximize coaptation of the mitral leaflets and a central spacer to fill the regurgitant orifice area.