THUNDER¿ Steerable Guidewire recall
THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of…
Why was THUNDER¿ Steerable Guidewire recalled?
Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
G13A00116 G13A00936 GV260 GV846
- Product
- THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of…
- Recalling firm
- Medtronic Vascular
- Quantity
- 1205
- Distribution
- Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.
- Recall date
- November 27, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)