Medtronic, Inc. - Neuromodulation: Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.

Recall number

Z-1062-2011

Recalling firm

Medtronic, Inc. - Neuromodulation

Product

Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.

Status

Terminated

Initiated

2011-01-14

Posted

2011-02-10

Terminated

2015-02-04

Reason

This letter provides important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure, and important patient management recommendations that will be added to our product labeling. A pocket fill is the inadvertent injection of all or some of the prescribed drug into the patients subcutaneous tissue, which includes the pum

Root cause

Other

Action

The firm, Medtronic, sent an "Urgent Medical Device Correction Cover " letter dated January 2011 to all customers. Enclosed with each letter, an "Urgent Medical Device Correction Important Clinical Information about Pocket Fills" letter dated January 2011 as well as a Clinician Refill Reference Card, Refill Appointment Cards, Physician Reply Card and a Self Addressed Stamped Envelope. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to always check the needle placement within the pump septum throughout the procedure to help perform a successful refill; be aware that the pump refill difficulty may increase due to a variety of factors (listed); monitor the patient closely for signs and symptoms of overdose according to the provided instructions. Note: Medtronic is in the process of supplementing the labeling related to improper injection with the information included in this communication. Patients with questions are encouraged to talk with their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday - Friday, 8 a.m. to 5 p.m. CDT. Physicians with medical questions related to this issue or Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday - Friday, 8 a.m. to 5 p.m. CDT. UPDATE - June 2013 - Medtronic Field Representative began notifying Healthcare Professionals June 3,2013,via visit to deliver and discuss the Pump Refill Procedure Safety Update letter. The letter informs clinicians that SynchroMed Implantable Infusion System labeling and the Clinician Refill Reference Card have been updated. The labeling and reference card were updated to provide important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure. The Medtronic Rep will complete a Physician Notification Confirmation form documenting the delivery of the information. A copy of the recall notification letter a

Quantity

91,369 total for all devices.

Distribution

Worldwide distribution: USA including DC and PR and countries including: AUSTRALIA, NEW ZEALAND, HONG KONG, TAIWAN, CHINA, SINGAPORE, MALAYSIA, INDONESIA, SOUTH KOREA, THAILAND, ARUBA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, FAROE ISLANDS, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JORDAN, KUWAIT, LEBANON, LITHUANIA, LUXEMBOURG, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NETHERLANDS ANTI LES, NORWAY, PANAMA, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, SAN MARINO, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VATICAN CITY.

Lot, serial or model codes

All units of these pump models are affected. Updates will be conducted on the Labeling, Training and Education Materials and the Refill Template which is included with the refill kits wil be redesigned.

510(k) numbers

not on file

PMA numbers

["P860004"]

Product code

LKK

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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