Argon Skater Introducer Set Recalled Due to Detaching Tungsten Coils
Argon Medical Devices is recalling Skater Introducer Sets because tungsten coils on the guidewire may detach. The recall affects 15,795 units distributed in China and Taiwan.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical defect in a medical device used for invasive procedures. While no specific injuries are reported in the source text, the risk of harm from detaching components during a procedure places this in the High severity category.
Plain-English summary
Argon Medical Devices, Inc. is recalling 15,795 units of the Skater Introducer Set 6F x 18cm. The recall is due to a defect where tungsten coils on the guidewire included in the kit were detaching. The affected products are identified by REF/UDI 651506300 and 655506300, with specific lot numbers listed in the recall documentation.
The Skater Introducer System is intended for fine needle puncture and tissue dilation to position a guidewire for catheter placement in non-vascular procedures. The defect poses a risk if the detached coils migrate or cause injury during the procedure.
The recalled units were distributed internationally to China and Taiwan. Healthcare providers and facilities that have these specific lot numbers should stop using the product and contact Argon Medical Devices for instructions on return or replacement.
The recalled product
- Product
- Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for cathet
- Manufacturer
- Argon Medical Devices, Inc
- Affected units
- 15,795
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF /LOT: 651506300/ 11267865
- 11271397
- 11277305
- 11287825
- 11293349
- 11288772
- 11290387
- 11263199
- 11262264
- 11258778
- 11254942
- 11253443 REF/ LOT: 655506300 / 11268009
- 11284776
- 11266592
- 11285976
- 11287826
- 11280359
- 11260512
- 11252843
- 11248583
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Argon Medical Devices, Inc
See all →- HighPeripherally Inserted Central Catheters Recalled Due to Hub Leaking and Cracking Risk
FDA (Devices) · 2026-08-05
- HighMidline Catheter Recalled Over Risk of Leaking or Cracking at Hub
FDA (Devices) · 2026-08-05
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereBone Marrow Tray kits recalled due to sterility failure
FDA (Devices) · 2026-07-22
Same hazard · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12