Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
PI CARDIA LTD · Transfemoral catheter, positing arm may detached due to weld issue.
Open FDA's page for this record- Cfres ID
- 222130
- Product res number
- Z-3213-2026
- Event date initiated
- 2026-07-06
- Event date posted
- 2026-09-17
- Recall status
- Open, Classified
- Res event number
- 99664
- Product code
- SCZ
- Product description
- Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
- Firm FEI number
- 3030471525
- Recalling firm
- PI CARDIA LTD
- Address 1
- 5, David Pikes St 5 David Pikes St
- City
- Rehovot
- Country
- Israel
- Additional info contact
- Hadas Givon 972-8-9484800
- Reason for recall
- Transfemoral catheter, positing arm may detached due to weld issue.
- Root cause description
- Process control
- Product quantity
- 46 units
- Distribution pattern
- US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
- Code info
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.
- 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 as appropriate.
- Harmonized identifiers (openFDA)
- Device name
- Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1254
- Device class
- 2
- K number
- DEN240017
- Registration number
- 3008729892, 3030471525, 3033307537
- FEI number
- 3033307537, 3030471525, 3002807555