CLASS I ONGOING Device recall · Reported 17 May 2023 · FDA Enforcement Report
Angioguard RX / XP Emboli Capture Guidewire System recalled by Cordis US
Cordis US is recalling Angioguard RX / XP Emboli Capture Guidewire System. The recall was initiated on 24 Mar 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1487-2023
- FDA event ID
- 91922
- Recalling firm
- Cordis US, Miami Lakes, FL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 24 Mar 2023
- FDA classified
- 11 May 2023
- Reported
- 17 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 24 Mar 2023 | Recall initiated by company | |
| 11 May 2023 | Classified by FDA | +48 days |
| 17 May 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI/DI 20705032056943; Lot Numbers: 35265335, 35264202
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
13 other products · FDA event 91922This product is part of a recall event; the main page for the event is Angioguard RX / XP Emboli Capture Guidewire System recalled by Cordis US.
More recalls from Cordis US
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cordis, REF: C09060ML, Smart Control Vascular Stent System recalled | Cordis US | Packaging Defects | 5 states |
| Device | CLASS II | Cordis, REF C10040ML, Smart Control Vascular Stent System recalled | Cordis US | Packaging Defects | 5 states |
| Device | CLASS II | Vista Brite Tip, Judkins Right recalled by Cordis US | Cordis US | Other | WA |
| Device | CLASS II | Mynxgrip 6f/7f recalled by Cordis US | Cordis US | Packaging Defects | 7 states |
| Device | CLASS II | Mynxgrip 5F recalled by Cordis US | Cordis US | Packaging Defects | 7 states |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |