Reported Sep 6, 2023 · Ongoing
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- PASCAL Precision Transcatheter Valve Repair System
- Models20000ISM and 20000IS
- Lot codes and dates
- Basic-UDI Code0690103S004PAS000BC
- Model/Serial Numbers
218 of 218 codes
20000ISM/108445491084455810921747107004241080984910809852108445641086494710903936109039371092175210921754108655801092175710921758109217601070043910776944107769661077698210809844108442431084425110844281108442921084457110848756108649211086492610864927108649421086494310864945108649501086558510865595108656031086565210865653108656541086565610865720108657231086572410865730108657311090394410903960109217291092173910921922109219241092192510921932109219411084426410844284108442881084458110844585
- Amount recalled
- 92
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Edwards Lifesciences, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.