PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS

Reason: 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.

Code information: 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

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