The Recall Desk
SevereFDA (Devices)·Z-1486-2023·Announced 2023-05-17

Emboli Capture Guidewire System Recalled Due to Potential Component Separation

Cordis US Corp recalls 54 units of the ANGIOGUARD RX/XP Emboli Capture Guidewire System due to potential separation of device components. This could delay procedures or result in unplanned intervention, including possible stroke.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall. Per the rubric, FDA Class I recalls cannot be scored below 4. The hazard involves potential separation of critical device components during medical procedures, which could lead to stroke or require unplanned surgical intervention.

Plain-English summary

Cordis US Corp has recalled 54 units of the ANGIOGUARD RX / XP Emboli Capture Guidewire System (Reference 701814RMC) due to a potential safety hazard. The product has been distributed worldwide.

There is a potential for separation of the delivery system and capture sheath during use. This separation could occur in situations involving intra-procedural delays, unplanned percutaneous intervention, or surgical intervention. If such separation occurs, the procedure may be delayed, unplanned intervention may be needed, or stroke could potentially result.

This is a Class I recall. The affected lot number is 35265661. Users of this device should contact Cordis US Corp for information about the recall and guidance on replacement options.

The recalled product

Product
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
Manufacturer
Cordis US Corp
Category
Medical Device — Cardiovascular Intervention
Hazard
Affected units
54

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 20705032056851
  • Lot Numbers: 35265661

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 14 recalled by Cordis US Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Related recalls

Same manufacturer · Cordis US Corp

See all →

Same hazard · component separation

See all →