Medtronic Dual Chamber Temporary Pacemaker, model 5388. Manufacturer: Medtronic, Inc., 710 Medtronic Parkway, Minneapoli

FDA device recall Z-0430-2011 · posted 2010-11-22 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Managment

Reason for recall

A subset of Model 5388 Dual-Chamber External Temporary Pulse Generators worldwide may be unable to power up or may power down unexpectedly. The issue presents itself in one of two ways. First, during startup, and prior to initiating patient therapy, the instrument may power down in 1 - 2 seconds. Second, the instrument may power up correctly, but power down at a later time while in use.

Action taken

Medtronic issued an Important Medical Device Correction letters, dated October 2010 and November 2010 to hospital's biomedical engineering department. The letter described the issue, how it presents, and stated that Medtronic will contact the hospitals to return affected product for servicing. The second letter reiterated that Medtronic would notify customers when FDA approves their design upgrade for returning devices for service. In the interim, hospitals should continue to use normally functioning devices. Cusotmers may contact Medtronic Instruments Technical Service at 800-638-1991 concerning this action.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LWP

Quantity affected

5,595 ( 2,696 US, 2,899 OUS) EXPANDED: 944 (852 US, 92 OUS)

Distribution

Worldwide Distribution: throughout USA and territories of Guam and Puerto Rico and to the countries of: Algeria, Argentina, Australia, Austria, Barbados, Belarus, Belgium, Bolivia, Bosnia And Herzegov

Date initiated

2010-10-11

Date posted

2010-11-22

Date terminated

2012-05-29

Location

Saint Paul, MN