Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
This recall has been terminated (originally issued March 28, 2013).
- Recall Initiated
- March 13, 2013
- Posted
- March 28, 2013
- Terminated
- November 21, 2013
- Recall Number
- Z-1017-2013
- Quantity
- 225 units
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use.
Distribution
Worldwide Distribution-USA including the states of FL, OH, and MN and the countries of Belgium, France Germany, Netherlands, Turkey, and United Kingdom.
Lot / Code Info
Lot number GFWA0387
Root Cause
Mixed-up of materials/components
Action Taken
Medtronic sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Medtronic requested any unused guidewires from the lot number to be quarantined, and returned by contacting the customer service phone number at 1-888-283-7868. A Customer Confirmation Certificate was requested to be faxed back to Medtronic at 651-367-0612.