medical MODERATE Updated 2026-09-23

PI CARDIA LTD recalls Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US

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Recalled Product

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

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Hazard / Issue

Transfemoral catheter, positing arm may detached due to weld issue.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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