FDA Medical Device Recalls (openFDA)
PI CARDIA LTD: Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
- Recall number
- Z-3213-2026
- Recalling firm
- PI CARDIA LTD
- Product
- Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
- Status
- Open, Classified
- Initiated
- 2026-07-06
- Posted
- 2026-09-17
- Terminated
- not on file
- 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 as appropriate.
- Quantity
- 46 units
- Distribution
- US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- SCZ
- Firm FEI
- 3030471525
- Firm city
- Rehovot
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28