FDA Device Recall Z-0022-2007: Medtronic Neuromodulation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0022-2007.

Recall Res Number

Z-0022-2007

Recalling Firm / Manufacturer

Medtronic Neuromodulation

FEI Number

2182207

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-06-06

Date Posted

2006-10-20

Date Terminated

2010-07-06

Product Code

LKK

Event Number

35595

Product Quantity

4,317 pumps

Product Description Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

Reason for Recall The Catheter Access Port (CAP) on SynchroMed EL pumps manufactured between March and July 1999 may detach from the main body of the pump, which can interrupt drug flow to the target site.

Action Details An Urgent medical Device Recall letter was sent to healthcare providers beginning June 06, 2006. The letter describes the issue, patient risk, identifies affected devices, and provides patient Management recommendations. The letter also asks for a response card to be returned to Medtronic. Patients may contact Medtronic Neurological Patient Services at 1-800-510-6735.

Distribution Pattern Worldwide distribution ---- including USA, Argentina, Barbados, Canada, Germany, India, Ireland, Italy, Mexico, The Netherlands, Spain, Switzerland, and United Kingdom.

Code Information / Serial Numbers Model 8627-10, serial numbers: NGE000001 - NGE000242R . Model 8627-18, serial numbers: NGF000001 - NGF003266R. Model 8627L-10, serial numbers: NGG000001R - NGG000068R, Model 8627L-18, serial numbers: NGH000001R - NGH001780R.

Related Establishments / Registrations

CONTECH MEDICAL, INC. Registration: 1221541 View Registration
MEDLINE INDUSTRIES, LP (Northpoint Services) Registration: 1422634 View Registration
Command Medical Products, LLC. Registration: 1526611 View Registration
MEDRON, LLC Registration: 1722746 View Registration
MEDTRONIC MINIMED Registration: 2032227 View Registration
TECHNICAL SERVICES FOR ELECTRONICS, INC. Registration: 2135338 View Registration
MEDTRONIC NEUROMODULATION Registration: 2182207 View Registration
SURGICAL TECHNOLOGIES, INC. Registration: 2183319 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
B. BRAUN US DEVICE MANUFACTURING LLC Registration: 2523676 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration
NextPhase Medical Devices, LLC Registration: 3003174284 View Registration
MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS Registration: 3004209178 View Registration
Plexus Manufacturing Sdn. Bhd. Registration: 3004593495 View Registration
ROBLING MEDICAL, LLC Registration: 3007829657 View Registration
Cirtec Medical Registration: 3009183442 View Registration
ALCYONE THERAPEUTICS, INC. Registration: 3011581884 View Registration
INTERA ONCOLOGY Registration: 3015537318 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
Infusyn Therapeutics Registration: 3030198397 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0022-2007

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer