Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: component-separation
stroke
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 →

Same manufacturer · Cordis US Corp

See all →

High
Cordis Smart Control Vascular Stent Size Mismatch Recalled
FDA (Devices) · 2025-04-09
High
Cordis Vascular Stent System Recalled Due to Incorrect Product Size
FDA (Devices) · 2025-04-09
High
Vista Brite Tip Guiding Catheter Manufactured at Incorrect Length
FDA (Devices) · 2025-03-19
Moderate
Cordis MYNXGRIP Vascular Closure Device Carton Labeling Error
FDA (Devices) · 2024-01-17
Moderate
Cordis MYNXGRIP 5F Vascular Closure Device Carton Labeling Error
FDA (Devices) · 2024-01-17

Same hazard · component separation