Edwards Lifesciences, LLC: Medical Device Recall in 2023 - (Recall #: Z-2479-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 27, 2023

Date Posted: September 6, 2023

Recall Number: Z-2479-2023

Event ID: 92804

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 92

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.

Voluntary or Mandated:

Voluntary: Firm initiated