- Recalling firm
- PI CARDIA LTD
- Reason for recall
- Transfemoral catheter, positing arm may detached due to weld issue.
- Affected products (lot / model / serial)
- 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.
- Units affected
- 46 units
- Distribution pattern
- US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
- Firm location
- Rehovot, N/A, Israel
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3213-2026
- Recall initiated
- July 6, 2026
- FDA classification date
- September 17, 2026
- FDA report date
- September 23, 2026
- FDA event ID
- 99664
- Last updated on HTM Vibe
- September 29, 2026