Recall Z-3213-2026 ยท SCZ Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
PI CARDIA LTD
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
| Date | Sep 17, 2026 (initiated Jul 6, 2026) |
| Status | Open, Classified |
| Reason | Transfemoral catheter, positing arm may detached due to weld issue. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 46 units |
| Distribution | US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.