ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
Reported: May 17, 2023 Initiated: March 24, 2023 #Z-1489-2023
Product Description
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
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.
Details
- Recalling Firm
- Cordis US Corp
- Units Affected
- 40 units
- Distribution
- Worldwide distribution.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC. Recalled by Cordis US Corp. Units affected: 40 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on May 17, 2023. Severity: Critical. Recall number: Z-1489-2023.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11