Edwards Lifesciences, LLC recalls PASCAL Precision Transcatheter Valve Repair System, Models:

Hazard / Issue

Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation.

Issued by

FDA

Distribution: International distribution to the countries of Austria, Belgium, Switzerland, Germany, Cyprus, Israel, UK, Greece, Ireland, Italy, Luxembourg, Poland.

Lot/Code Info: Basic-UDI Code: 0690103S004PAS000BC. Model/Serial Numbers: 20000ISM/10844549, 10844558, 10921747, 10700424, 10809849, 10809852, 10844564, 10864947, 10903936, 10903937, 10921752, 10921754, 10865580, 10921757, 10921758, 10921760, 10700439, 10776944, 10776966, 10776982, 10809844, 10844243, 10844251, 10844281, 10844292, 10844571, 10848756, 10864921, 10864926, 10864927, 10864942, 10864943, 10864945, 10864950, 10865585, 10865595, 10865603, 10865652, 10865653, 10865654, 10865656, 10865720, 10865723, 10865724, 10865730, 10865731, 10903944, 10903960, 10921729, 10921739, 10921922, 10921924, 10921925, 10921932, 10921941, 10844264, 10844284, 10844288, 10844581, 10844585, 10848729, 10848730, 10848739, 10848740, 10848744, 10848746, 10848747, 10848750, 10848753, 10864833, 10864838, 10864840, 10864844, 10864897, 10865584, 10865613, 10865616, 10865618, 10865649, 10865719, 10865722, 10865727, 10921733, 10921734, 10921918, 10951672, 10951679, 10951683, 10951685, 10951687, 10951691, 10865732, 10865735, 10903975, 10809836, 10848723, 10921930, 10844300, 10844302, 10844305, 10864959, 10864960, 10921926, 10921927, 10844551, 10844563, 10844566, 10853110, 10903977, 10921748, 10921750, 10922081, 10922089, 10922093, 10922096, 10922098, 10922102, 10922103, 10922106, 10922107, 10922108, 10922110, 10922111, 10922116, 10922118, 10922119, 10922121, 10922122, 10922126, 10922127, 10922129, 10922133, 10922138, 10922140, 10922142, 10951734, 10951737, 10951740, 10951741, 10951743, 10951744, 10951745, 10951747, 10951748, 10951749, 10951750, 10951751, 10951753, 10951754, 10951756, 10951757, 10951758, 10951760, 10951761, 10951763, 10969562, 10969572, 10969573, 10969576, 10969577, 10969579, 10969583, 10969587, 10969591, 10969592, 10969593, 10969595, 10969597, 10969598, 10969599, 10969601, 10969603, 10969606, 10969611, 10969616, 10969619, 10969620, 10969625, 10969629, 10848722, 10865736, 10904022, 10904024, 10904026, 10904028, 10904029, 10864924, 10864928, 10864931, 10864936, 10864939, 10865549, 10865716, 10921861. 20000IS/10875150, 10853171, 10853233, 10853196, 10853203, 10853208, 10853213, 10853222, 10853235, 10875121, 10875124, 10875126, 10875131, 10875137, 10875138, 10875143, 10875145, 10875146, 10875152, 10853206, 10875154, 10875123, 10875136, 10875142, 10875144