FDA · Medical devices ·
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US recall
PI CARDIA LTD recalled Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US on September 23, 2026 because of transfemoral catheter, positing arm may detached due to weld issue. It was sold nationwide.
Why it was recalled
Transfemoral catheter, positing arm may detached due to weld issue.
What's recalled
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Quantity: 46 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- PI CARDIA LTD, Rehovot, N/A
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York. - Status
- Ongoing
- Recall number
- Z-3213-2026
- Source
- U.S. Food and Drug Administration
More medical devices recalls
Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector
· Olympus Corporation of the AmericasMedline convenience kits containing Healthmark Instrument Channel Brushes
· Medline Industries, LPMidmark IQvitals Zone
· Midmark CorporationAchieva 3.0T; Model Numbers (REF)
· Philips North America LlcAutomated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1
· Abiomed, Inc.INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set
· CooperSurgical, Inc.
· Olympus Corporation of the AmericasMedline convenience kits containing Healthmark Instrument Channel Brushes
· Medline Industries, LPMidmark IQvitals Zone
· Midmark CorporationAchieva 3.0T; Model Numbers (REF)
· Philips North America LlcAutomated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1
· Abiomed, Inc.INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set
· CooperSurgical, Inc.