Summary
The FDA issued a Class I for ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC by Cordis US Corp. Reason: 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 a.
Details
Source
Device Recall
External ID
Z-1489-2023
Action Date
2023-05-17
Status
Ongoing
Category
device
Product Description
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
Lot/Code Info: UDI/DI 20705032054789; Lot Numbers: 35264223
Quantity Affected: 40 units
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.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-24
Company
Miami Lakes, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 160 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cordis US Corp has 26 FDA actions in our database, including 22 recalls and 4 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cordis US Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cordis US Corp have FDA actions?
Cordis US Corp has 26 FDA actions in our database, including 22 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1489-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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