FDAFDA · Food and drugs·Recall number Z-0265-2014
ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
Published November 27, 2013 · Recall initiated: October 21, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Vascular
- Distributor
- 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.
- Lot
- 0006752371 0006752383 0006752385 0006759937 0006759939 0006759941 0006769772 0006781453 0006781454 0006781455 0006808160 0006808161 0006808164 0006808165 0006808166 0006808167 0006831243 0006840866 0006840878 0006840879 0006866694 0006866696 0006866697 0006873688 0006873692 0006873694
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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