Recall Z-0265-2014
Medtronic Vascular · initiated October 21, 2013
Class I – dangerous or defective products that could cause serious health problems or death
Product
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.
Codes / lots: 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
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-0265-2014
- Initiated
- October 21, 2013
- Posted by FDA
- November 15, 2013
- Terminated
- December 15, 2014
- Product code
- DQX – Wire, Guide, Catheter
- Quantity
- 1674
- 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-0266-2014 Class I | COUGAR Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic…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 |