Z-1496-2023Class I

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE

Name: Z-1496-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
Creator: Cordis US Corp
Published: 2023-03-24
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2023-03-24 / Open, Classified / root cause: supplier

FDA source

Cordis US Corp began a recall of ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE on 2023-03-24. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1496-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-03-24
Posted: 2023-05-11
Recalling firm: Cordis US Corp.
Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
Product code: NTE Temporary Carotid Catheter For Embolic Capture
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.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Distribution: Worldwide distribution.
Product codes and lots: UDI/DI 20705032056929; Lot Numbers: 35267611

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1496-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1483-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11
Z-1484-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11
Z-1485-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11
Z-1486-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11
Z-1487-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11
Z-1488-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11
Z-1489-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11
Z-1490-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11
Z-1491-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11
Z-1492-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11
Z-1493-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11
Z-1494-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11
Z-1495-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11
Z-1496-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11

Product code NTE

K220654Class IIANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis Corporation / cleared 2022-04-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)