PI CARDIA LTD recalls Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
- Recalling company
- PI CARDIA LTD
- Product
- Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
- Reason
- Transfemoral catheter, positing arm may detached due to weld issue.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 6, 2026
- Reported
- Sep 23, 2026
- Distribution
- US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
- Status
- Ongoing
- Quantity
- 46 units
- Lot / 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.
- Company location
- Rehovot, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3213-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3213-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.