The Recall Desk
SevereFDA (Devices)·Z-1494-2023·Announced 2023-05-17

Emboli Capture Guidewire System recalled for component separation risk

The ANGIOGUARD RX/XP Emboli Capture Guidewire System is being recalled because the delivery system and capture sheath may separate during procedures, potentially causing stroke or requiring emergency surgical intervention.

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: FDA Class I medical device recall. Per the severity rubric, Class I recalls never score below 4. While no illnesses or deaths have been reported, the potential for component separation in a critical interventional device, with consequences including stroke or emergency intervention, justifies the Severe classification.

Plain-English summary

The ANGIOGUARD RX/XP Emboli Capture Guidewire System, manufactured by Cordis US Corp, is being recalled by the FDA due to a potential risk of separation between the delivery system and capture sheath during use.

If the components separate during a procedure, consequences may include intra-procedural delay, need for unplanned percutaneous or surgical intervention, or stroke. The affected devices bear UDI/DI 20705032056738 and include lot numbers 35265658, 35264211, 35264225, and 35265647. These devices have been distributed worldwide.

This is a Class I recall. Healthcare providers using affected devices should contact Cordis US Corp for information about replacement devices or further instructions.

The recalled product

Product
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
Manufacturer
Cordis US Corp
Category
Medical Device
Hazard
Affected units
27

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 (5)

  • UDI/DI 20705032056738
  • Lot Numbers: 35265658
  • 35264211
  • 35264225
  • 35265647

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

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Same hazard · component separation

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