Edwards Lifesciences, LLC PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Brand
Edwards Lifesciences, LLC
Lot Codes / Batch Numbers
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
Products Sold
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
Edwards Lifesciences, LLC is recalling PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS due to Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resis. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 7/27/23, recall notices were sent to customers and distributors who were asked to do the following: 1) Stop using and work with your firm representative to return affected devices. 2) Share this notice with the appropriate clinical staff at your site. 3) Complete and return the customer acknowledgement form. 4) Distributors: Notify your customers by sending this customer notification to any of your customers who have purchased the impacted devices.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026