Edwards Lifesciences has issued a recall for the guidesheath (model number: 10000GS and 10000GSCE) that is used in conjunction with the Pascal system for the transcatheter repair of mitral valve regurgitation. According to a letter sent to physicians, there is a potential for damage to the inner liner of the guidesheath because of a manufacturing issue. Based upon current information, the letter reports, the rate of this occurrence is approximately 0.5%, or 1 out of 200 units.
The letter adds that there are no reports of patient adverse events or injury related to this occurrence; however, it notes possible embolisation of a segment of the inner liner material could happen if a guidesheath with a damaged inner liner is used. There is no information to suggest that previously implanted patients are affected, the letter reports.
Operators are advised not to use their current inventory of Pascal guidesheaths and to return them to Edwards. Only the guidesheath is affected by this recall notice—not the entire Pascal system.
List of Affected Lot Numbers: 61809096; 61846561; 61960546; 61972605; 62022424; 62022425; 62149867; 62149868; 62202695; 62225282; 62249074; 62249075; 62249076; 62354054; 62429249; 62556772; 62718664; and 62718666.