Pi-Cardia Inc. ShortCut recall
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Why was Pi-Cardia Inc. ShortCut recalled?
Transfemoral catheter, positing arm may detached due to weld issue.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
- Recalling firm
- PI CARDIA LTD
- Quantity
- 46 units
- Distribution
- US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
- Recall date
- September 23, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)