FDA Device recall Z-2479-2023

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

FDA Device
Class II
ongoing
Published 2023-09-06

On 2023-09-06 the FDA classified a Class II recall of PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS by Edwards Lifesciences, citing 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 rele….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2479-2023
Classification	Class II
Status	ongoing
Initiated	2023-07-27
Published	2023-09-06
Last updated	2026-09-13 11:56 UTC
Company	Edwards Lifesciences
Distribution	n/a

Product

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.

Identifiers

code_info	Basic-UDI Code: 0690103S004PAS000BC. Model/Serial Numbers: 20000ISM/10844549, 10844558, 10921747, 10700424, 10809849,… 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, 1

code_info

Basic-UDI Code: 0690103S004PAS000BC. Model/Serial Numbers: 20000ISM/10844549, 10844558, 10921747, 10700424, 10809849,…

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, 1

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2479-2023%22

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