CLASS II ONGOING Device recall · Reported 29 Sep 2021 · FDA Enforcement Report
Scorpion Portal Vein Access Set recalled by Argon Medical Devices
Argon Medical Devices is recalling Scorpion Portal Vein Access Set, distributed nationwide in the US. The recall was initiated on 8 Jul 2021 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-2501-2021
- FDA event ID
- 88520
- Recalling firm
- Argon Medical Devices, Athens, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jul 2021
- FDA classified
- 21 Sep 2021
- Reported
- 29 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Syringes & Needles
Timeline
| 8 Jul 2021 | Recall initiated by company | |
| 21 Sep 2021 | Classified by FDA | +75 days |
| 29 Sep 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
Where it was distributed
U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
Questions about this recall
Why was it recalled?
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Which lots are affected?
Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609
Where was it sold?
U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
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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