Use cautionMedical device recall · FDA · Published July 6, 2026
Pi-Cardia ShortCut Catheter Recall: Weld Issue May Cause Detachment
Pi-Cardia recalls ShortCut catheters with weld defect that could detach the positioning arm, risking injury. Affected units have specific serial numbers.
“Pi-Cardia ShortCut Catheter Recall: Weld Issue May Cause Detachment.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/1134809-pi-cardia-shortcut-catheter-recall-weld-issue-may-cause-detachment. Based on FDA recall #Z-3213-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3213-2026%22&limit=1).
The Food and Drug Administration announced on July 6, 2026, that PI CARDIA LTD is recalling Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US transfemoral catheters because the positing arm may detach due to a weld issue.
How to tell if you have it
Brand: Pi-Cardia
Product: Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
The transfemoral catheter's positing arm may detach due to a weld issue.
Context
GovInfoNow's records show other recent recalls of similar products include Medline Intermittent Latex Catheter Recall: Connector Detachment Risk (2026-05-04), Medline Medical Procedure Kits: Catheter Issues May Cause Premature Detachment (2026-05-04) and Medline Medical Procedure Kits Recall: Catheter Issues May Cause Detachment (2026-05-04).
How to tell if you have this one
Check the serial number on your catheter. Affected units have specific serial numbers listed in the recall notice: SC919 through SC968 (excluding SC955 and SC959).
Brand
Pi-Cardia
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Look for the serial number on your Pi-Cardia ShortCut catheter. Affected units have specific serial numbers listed in the recall notice.
Contact Manufacturer
Reach out to Pi-Cardia for guidance on next steps if your catheter is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Delaware, Kansas, Massachusetts, New Hampshire, New York, Pennsylvania, Utah.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3213-2026 (July 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3213-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.