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Open, Classified

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

FDA Recall Z-3213-2026 · Posted 2026-09-17

Recalling FirmPI CARDIA LTD
Recall StatusOpen, Classified
Product CodeSCZ
Date Initiated2026-07-06
Product Quantity46 units

Reason for Recall

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

Firm Action

On September 3, 2026 Pi-Cardia issued a Urgent Medical Device Recall Update notification to affected consignees via email. This update provided additional information on the risk to health as well as consignee instructions. Original notification was issued July 9, 2026, Pi Cardia Ltd. informed consignees the following: 1. A member of the Pi-Cardia team will contact you promptly with instructions regarding identification and return of any affected inventory. 2. If you have questions in the meantime, please contact your Pi-Cardia representative. 3. Pi-Cardia will provide additional updates as appropriate.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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