The Recall Desk
SevereFDA (Devices)·Z-3213-2026·Announced 2026-09-23

Pi-Cardia ShortCut Transfemoral Catheter Recalled for Detachment Risk

Pi-Cardia is recalling 46 ShortCut transfemoral catheters because the positioning arm may detach due to a weld issue.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (detachment) in a medical device, which meets the criteria for a Severe rating.

Plain-English summary

Pi-Cardia Ltd is recalling 46 units of the ShortCut transfemoral catheter (REF: Z-A-20.003-US). The recall is due to a weld issue that may cause the positioning arm to detach.

The affected units were distributed nationwide in Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York. The specific serial numbers affected are listed in the recall documentation under lot SCUS-00013.

Healthcare providers should stop using the affected devices and contact Pi-Cardia for instructions on return or replacement.

The recalled product

Product
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Manufacturer
PI CARDIA LTD
Category
Medical Device — Catheter
Hazard
Affected units
46

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • SC920
  • SC921
  • SC923
  • SC924
  • SC925
  • SC926
  • SC927
  • SC928
  • SC929
  • SC930
  • SC931
  • SC932
  • SC933
  • SC934
  • SC935
  • SC936
  • SC937
  • SC938
  • SC939
  • SC940

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Related recalls

Same hazard · structural defect

See all →