[Recalled] ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC — There is a potential for separation of the ANGIOGUARD RX / XP delivery system a… | FDA 2023-03-24

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Cordis US Corp

• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM — Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC — Class I
• Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only — Class II
• MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites. — Class II
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM — Class I
• Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems. — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.