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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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.
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