FDA Device Recall Z-0040-2008: Medtronic Neuromodulation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0040-2008.

Recall Res Number

Z-0040-2008

Recalling Firm / Manufacturer

Medtronic Neuromodulation

FEI Number

2182207

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2007-06-25

Date Posted

2007-10-12

Date Terminated

2010-10-08

Product Code

EZW

Event Number

44740

Product Quantity

1885

Product Description Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for Urinary Control.

Reason for Recall Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).

Action Details Begining on July 11, 2007 a letter to the physicians was sent informing them of the issue and patient management for the two issues. The letter includes a Cover Letter, A Reply Form, and two Recall letters explaining the issue in detail.

Distribution Pattern Nationwide and the Netherlands.

Code Information / Serial Numbers All serial numbers within these catalog/model numbers are affected (Model 3023, Catalog Number 8870MMB01 and 8870NNB01)

Related Establishments / Registrations

Sterigenics U.S., LLC Registration: 1319639 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
TECHNICAL SERVICES FOR ELECTRONICS, INC. Registration: 2135338 View Registration
MEDTRONIC NEUROMODULATION Registration: 2182207 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA Registration: 2649622 View Registration
AXONICS, INC. Registration: 3002968685 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS Registration: 3004209178 View Registration
Plexus Manufacturing Sdn. Bhd. Registration: 3004593495 View Registration
Jabil Circuit (Shanghai) Ltd. Registration: 3005210579 View Registration
Cirtec Medical Registration: 3009183442 View Registration
Medtronic Distribution Center Registration: 3009380063 View Registration
AvailMed S.A.De C.V. Registration: 3010291427 View Registration
Jabil Circuit (Shanghai) Ltd. Registration: 3010972758 View Registration
NEUSPERA MEDICAL, INC. Registration: 3014845032 View Registration
BOULDER BIOMED LLC Registration: 3015151147 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
CENTERPIECE S. DE R.L DE C.V (sterilization site) Registration: 3019807891 View Registration
Saluda Medical Pty. Ltd. Registration: 3021836309 View Registration

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Medical Device Recall: Z-0040-2008

Recall Parameters & Description

Related Establishments / Registrations

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