PI CARDIA LTD recalls Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
- Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
- Process control
Reason for recall
Transfemoral catheter, positing arm may detached due to weld issue.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Pi-Cardia Inc. ShortCut REF:Z-A-20.003-US46 affected lotsSC919SC920SC921SC923SC924SC925SC926SC927
+38 more
SC928SC929SC930SC931SC932SC933SC934SC935SC936SC937SC938SC939SC940SC941SC942SC943SC944SC945SC946SC947SC948SC949SC950SC951SC952SC953SC954SC956SC957SC958SC960SC961SC962SC963SC964SC966SC967SC968
What the firm is doing
On September 3, 2026 Pi-Cardia issued a Urgent Medical Device Recall Update notification to affected consignees via email. This update provided additional information on the risk to health as well as consignee instructions. Original notification was issued July 9, 2026, Pi Cardia Ltd. informed consignees the following: 1. A member of the Pi-Cardia team will contact you promptly with instructions regarding identification and return of any affected inventory. 2. If you have questions in the meantime, please contact your Pi-Cardia representative. 3. Pi-Cardia will provide additional updates as appropriate.
DistributionShow detailsHide
US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3213-2026
- FDA device classification · SCZOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1254The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find PI CARDIA LTDSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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