Recall Z-3213-2026
Pi Cardia Ltd · initiated July 6, 2026
Product
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Codes / lots: UDI-DI - (01)7290020101242 All serial numbers in the affected lot SCUS-00013: SC919, SC920, SC921, SC923, SC924, SC925, SC926, SC927, SC928, SC929, SC930, SC931, SC932, SC933, SC934, SC935, SC936, SC937, SC938, SC939, SC940, SC941, SC942, SC943, SC944, SC945, SC946, SC947, SC948, SC949, SC950, SC951, SC952, SC953, SC954, SC956, SC957, SC958, SC960, SC961, SC962, SC963, SC964, SC966, SC967 and SC968.
Reason for recall
Transfemoral catheter, positing arm may detached due to weld issue.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-3213-2026
- Initiated
- July 6, 2026
- Posted by FDA
- September 17, 2026
- Product code
- SCZ – Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
- Quantity
- 46 units
- Distribution
- US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
- Recalling firm
- Pi Cardia Ltd, Rehovot