Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10

FDA device recall Z-1580-2013 · posted 2013-06-25 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und

Action taken

Medtronic sent an Urgent Medical Device Correction letter dated May 2013, to all affected customers. The letter described the issue of the pump's potentially shorting, how to identify if a pump is affected, and provided ongoing patient management recommendations. The Medtronic Rep would complete a Physician Notification Confirmation Form. A copy of the recall notification letter and the completed Confirmation Form is to be left with the physician. Customers with questions were instructed to call 1-800-707-0933. For questions regarding this recall call 763-526-9738.

Root cause

Device Design

Status

Terminated

Product code

LKK

Quantity affected

261,109 total devices estimated implanted Worldwide

Distribution

worldwide

Date initiated

2013-06-03

Date posted

2013-06-25

Date terminated

2015-11-16

Location

Minneapolis, MN