Z-3213-2026Class II

Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US

Name: Z-3213-2026 Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Creator: Pi Cardia Ltd
Published: 2026-07-06
License: https://open.fda.gov/license/

Pi Cardia Ltd / initiated 2026-07-06 / Open, Classified

FDA source

Recall record

Recall number: Z-3213-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-06
Posted: 2026-09-17
Recalling firm: Pi Cardia Ltd
Product: Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Product code: SCZ Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Reason for recall: Transfemoral catheter, positing arm may detached due to weld issue.
FDA 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 in commerce: 46 units
Distribution: US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3213-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3213-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-17

Product code SCZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)