Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtron

FDA device recall Z-0567-2013 · posted 2012-12-19 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

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.

Action taken

Medtronic beginning November 15, 2012 , initiated a retrieval of unused inventory in the field. In the US, three customers were identified. Medtronic field representatives visited these US accounts to facilitate product identification and removal. If product was removed a letter was provided to the facility describing the recall. The letter dated November 2012, "Medtronic Medical Device recall" was addressed to the Hospital. Beginning on December 3, 2012, Medtronic mailed healthcare professional letters to physician who have used the affected product. The Medtronic " Medical Device Recall" letter was dated November 2012. The letter identified the problem, the product involved in the recall, and provided advise if the product was used. A reply card was provided to each physician to confirm they have received and understood the communication. For further questions please call (763) 514-2000.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MHY

Quantity affected

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, S

Date initiated

2012-12-03

Date posted

2012-12-19

Date terminated

2013-11-14

Location

Minneapolis, MN