The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the d
Summary
The FDA issued a Class II for The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness by Stryker Neurovascular. Reason: Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: t.
Details
Source
Device Recall
External ID
Z-1740-2024
Action Date
2024-05-08
Status
Ongoing
Category
device
Product Description
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each catheter. The rotating hemostasis valve is typically y shaped with a female luer lock and a manual hemostasis valve. The female port allows for aspiration and contrast injections while the hemostasis valve allows direct arterial access when using other devices such as guidewires and/or interventional devices.
Lot/Code Info: UDI-DI: 07613327313895, Lot: 0000486382, Expiration: 17-Jul-2025
Quantity Affected: 43
Reason for Recall
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.
Distribution
US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA, MI, MS, SC, IL.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-03
Company
Fremont, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 175 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Neurovascular has 26 FDA actions in our database, including 14 recalls and 12 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Stryker Neurovascular) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Neurovascular have FDA actions?
Stryker Neurovascular has 26 FDA actions in our database, including 14 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1740-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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