Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa PC neur

FDA device recall Z-2259-2014 · posted 2014-08-18 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.

Action taken

The firm, Medtronic, notified their Consignees on 07/14/2014 via telephone of the recall. Medtronic representative used telephone script to convey the information. The script was directed to Risk Management or Inventory Management. The caller was to inform consignees of the problem and product being recalled. Advised consignees to quarantine the product and provided the Medtronic Device Removal Reply Form to the consignees via e-mail or Fax. The Reply Form included contact information which was to call 1-800-633-8766 in case they needed to contact a Medtronic representative. The completed form is to be faxed back to 1-800-897-3899 or e-mail a PDF to neuro.quality@medtronic.com. If you have any questions, call 763-526-1294.

Root cause

Process control

Status

Terminated

Product code

MHY

Quantity affected

6

Distribution

Distributed in the states of: MA, NC, OH, and TX.

Date initiated

2014-07-14

Date posted

2014-08-18

Date terminated

2014-10-06

Location

Minneapolis, MN