Recall Z-0266-2014
Medtronic Vascular · initiated October 21, 2013
Class I – dangerous or defective products that could cause serious health problems or death
Product
COUGAR Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another
Codes / lots: G13A00805 G13A00814 G13A00815 G13A01447 G13A01450 GW547
Reason for recall
Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
FDA-determined cause: Nonconforming Material/Component
Action taken
The firm, Medtronic, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory; return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required). Should have any questions, please contact your Medtronic Representative or call 763-526-2513. Notifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming their receipt of the notification. 100% customer confirmations will be required from the additional consignees.
Details
- Recall number
- Z-0266-2014
- Initiated
- October 21, 2013
- Posted by FDA
- November 15, 2013
- Terminated
- December 15, 2014
- Product code
- DQX – Wire, Guide, Catheter
- Quantity
- 20
- 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…
- Recalling firm
- Medtronic Vascular, Danvers, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0261-2014 Class I | Cougar Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S…Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | 10/21/2013Terminated |
| Z-0262-2014 Class I | Zinger Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS…Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | 10/21/2013Terminated |
| Z-0263-2014 Class I | THUNDER Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S…Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | 10/21/2013Terminated |
| Z-0264-2014 Class I | ProVia CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS…Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic guide… | 10/21/2013Terminated |
| Z-0265-2014 Class I | ATTAIN HYBRID Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid…Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | 10/21/2013Terminated |
| Z-0267-2014 Class I | THUNDER Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide…Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | 10/21/2013Terminated |
| Z-0268-2014 Class I | ZINGER Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S…Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | 10/21/2013Terminated |