Skip to content

ANGIOGUARD recallZ-1487-2023 · Cordis US Corp · initiated Mar 24, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cordis US Corp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Vendor change control

What the company is doing

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.

Recall details

Recall number
Z-1487-2023
Status
Open, Classified
Initiated by the company
Mar 24, 2023
Posted by the FDA
May 11, 2023
Recalling firm
Cordis US Corp
Quantity
146 units
Product code
NTE
FDA submissions
K220654
Distribution
Worldwide distribution.

Product description

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

Code information (models, lots, serial numbers)

UDI/DI 20705032056943; Lot Numbers: 35265335, 35264202

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

7 devices cleared under K220654 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91922).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page