FDAClass IMay 17, 2023

Angioguard recall

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC

Why was Angioguard recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 20705032054802; Lot Numbers: 35264208, 35264212, 35265329, 35265654, 35265649, 35265667.

Product
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
Recalling firm
Cordis US Corp
Quantity
684 units
Distribution
Worldwide distribution.
Recall date
May 17, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls