CLASS II ONGOING Device recall · Reported 8 May 2024 · FDA Enforcement Report
The Distal Access Catheter is a single-lumen, braided shaft recalled
Stryker Neurovascular is recalling The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter, distributed nationwide in the US. The recall was initiated on 3 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1740-2024
- FDA event ID
- 94347
- Recalling firm
- Stryker Neurovascular, Fremont, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Apr 2024
- FDA classified
- 1 May 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 3 Apr 2024 | Recall initiated by company | |
| 1 May 2024 | Classified by FDA | +28 days |
| 8 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA, MI, MS, SC, IL.
Nationwide AlabamaColoradoFloridaIllinoisLouisianaMichiganMississippiNorth CarolinaNew JerseyPennsylvaniaSouth CarolinaTexas
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 07613327313895, Lot: 0000486382, Expiration: 17-Jul-2025
Where was it sold?
US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA, MI, MS, SC, IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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