Class II — PI CARDIA LTD
| Recalling firm | Pi-Cardia LtD |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Transfemoral catheter, positing arm may detached due to weld issue. |
| Product | Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US |
| Quantity | 46 units |
| Distribution | US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York. |
| Initiated | 2026-07-06 |
| Classified | 2026-09-17 |
| Recall number | Z-3213-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PI CARDIA LTD (Z-3213-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99664/
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