Medtronic Archer Super Stiff Guidewire Recalled for Coating Separation Risk
Medtronic is recalling Archer Super Stiff Guidewires because the PTFE coating may separate from the wire during use.
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 involves a medical device with a potential for structural failure (coating separation) during use, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic Inc. Cardiac Rhythm Disease Management is recalling 225 units of the Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. The recall affects lot number GFWA0387. These medical devices are intended to facilitate catheter placement and exchange during procedures in the aorta.
The recall was initiated because the PTFE (Teflon) coating on the guidewire has the potential to separate from the wire during in-vivo use. This defect could compromise the integrity of the device during medical procedures.
The affected units were distributed worldwide, including in the United States (specifically Florida, Ohio, and Minnesota) and in Belgium, France, Germany, the Netherlands, Turkey, and the United Kingdom. Healthcare providers and facilities should stop using the affected lot and contact Medtronic for further instructions.
The recalled product
- Product
- Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Affected units
- 225
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 (1)
- Lot number GFWA0387
Distribution
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