Medtronic recall
Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto…
Why was Medtronic recalled?
Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), which may contain a damaged winged connector boot. The connector boot may not have been molded properly and may be cracked. Approximately 14% of the 140 affected extension kits may contain a damaged radiopaque winged connector boot.
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?
NHU236350V to NHU236373V; NKN037257V to NKN037259V; NKN037372V to NKN037387V; NKN037476V to NKN037507V; NKN037692V to NKN037698V; NKN037772V to NKN037779V; NKN037790V to NKN037810V; NKN037812V to NKN037840V.
- Product
- Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto…
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 140 units
- Distribution
- Worldwide Distribution -- USA (nationwide) including the states of CT, MI, NH, NY, OH, PA and VT., and the countries of AUSTRALIA, JAPAN, BELGIUM, FRANCE, GERMANY, ITALY, NETHERLANDS, POLAND, SPAIN, SWITZERLAND, TURKEY and UNITED KINGDOM.
- Recall date
- December 26, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)