Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / 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
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
International distribution to the countries of Austria, Belgium, Switzerland, Germany, Cyprus, Israel, UK, Greece, Ireland, Italy, Luxembourg, Poland.
Recall record
- Recalling firm
- Edwards Lifesciences, LLC
- Product type
- Devices
- Recall number
- Z-2479-2023
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Irvine, CA
- Recall initiated
- 2023-07-27
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2479-2023 · Source: openFDA enforcement.