Medtronic Neuromodulation: Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc., Villalba, Puerto Rico, USA. Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide. Model 3998 lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord. The lead consists of two polyurethane lead bodies joined to one silicone rubber paddle. The lead has two parallel rows of four platinum iridium electrodes on the distal end.

Recall number

Z-2241-2008

Recalling firm

Medtronic Neuromodulation

Product

Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc., Villalba, Puerto Rico, USA. Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide. Model 3998 lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord. The lead consists of two polyurethane lead bodies joined to one silicone rubber paddle. The lead has two parallel rows of four platinum iridium electrodes on the distal end.

Status

Terminated

Initiated

2008-05-21

Posted

2008-09-18

Terminated

2010-10-08

Reason

Medtronic is recalling certain lots of Model 3998 SPECIFY surgical lead kits due to a package mislabeling issue. The package labeling incorrectly states the lead length is 28 cm in length when it should state 20 cm. Recalled lots are to be returned for replacement or credit.

Root cause

Software design (manufacturing process)

Action

In May 2008, a Product Recall letter was issued to customers. Medtronic Field Representatives are to contact customers with consigned or unregistered sold product to remove it and return it to Medtronic. A Leave-Behind letter will be provided to customers, explaining the issue and the reason for removal of product. Recalled devices will be returned for replacement or credit. The Medtronic representative will complete and return a Reply Card, which documents the notification of the customer. If you have questions or comments, contact your Medtronic representative.

Quantity

3669 (however only 962 units are scope of recall, because they are sold or in consignment AND are not registered implants

Distribution

US distribution only to: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY

Lot, serial or model codes

V004442, V004456, V004457, V004541, V004644, V005789, V005838, V005884, V005952, V006010, V006011, V006497, V006610, V006732, V006888, V006937, V007136, V007224, V007342, V007451, V007565, V007729, V007781, V007911, V008174, V008257, V008387, V008638, V008639, V008729, V008902, V009060, V009191, V009278, V009352, V009353, V009630, V010099, V010124, V010125, V010366, V010367, V010602, V010744, V010896, V011057, V011091, V011215, V011257, V011299, V011406, V011457, V011552, V011610, V011627, V011860, V011958, V011977, V012040, V012123, V012202, V012238, V012260, V012411, V012571, V012618, V012935, V013158, V013231, V013331, V013489, V013615, V013745, V013787, V013837, V013862, V014190, V014320, V014426, V014454, V014660, V014785, V015071, V015166, V015327, V015626, V016195, V016445, V016489, V017182, V017731, V017927, V019145, V019452, V019569, V019909, V020188, V020688, V020904, V021560, V021753, V022880, V023339, V023517, V025268, V025500, V025707, V026020, V026436, V027462, V027804, V028474, V029383, V029983, V030442, V031317, V032070, V032560, V034825, V034832, V035769, V036156, V036810, V036857, V038530, V041066, V041365, V042627, V043757, V043759, V044336, V044850, V045723, V047365, V050371, V052566, V053142, V054607, V056045, V057371, V060415, V062321, V068860, V069647, V077531, V080086, V082162, V084570, V086942, V090294, V091959, V095777, V102426

510(k) numbers

["K971756"]

PMA numbers

not on file

Product code

GZB

Firm FEI

2182207

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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