Guidant Corporation: MERIDIAN (model nos. 476, 976, 1176 and 1276) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. MERIDIAN pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, sine offering adaptive-rate therapy. MERIDIAN pacemakers use an accelerometer that allows the pacing rate to adapt to the patient's changing metabolic demand as it responds to patient activity.

Recall number

Z-1033-05

Recalling firm

Guidant Corporation

Product

MERIDIAN (model nos. 476, 976, 1176 and 1276) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. MERIDIAN pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, sine offering adaptive-rate therapy. MERIDIAN pacemakers use an accelerometer that allows the pacing rate to adapt to the patient's changing metabolic demand as it responds to patient activity.

Status

Terminated

Initiated

2005-07-18

Posted

2005-07-28

Terminated

2007-01-05

Reason

A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.

Root cause

Other

Action

INITIAL RECALL Urgent medical Device Safety Information & Corrective Action letter dated 07/18/05 was issued to physicians listing clinical Implications and patient management recommendations. EXPANDED RECALL Press was issued January 23, 2006. Urgent Medical Device Safety Information & Corrective Action letter, dated 01/21/06, was issued to physicians listing a summary of previous communication to physicians, advisory population update, and information relative to a second population of devices manufactured between October 19, 1998 and December 5, 2000. This letter gives the observed rate of occurrence, clinical implications, projected rate of occurrence and recommendations.

Quantity

INITIAL RECALL 7,518. EXPANDED RECALL 4,708

Distribution

worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cyprus, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guyana, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Polynesia, Portugal, Reunion, Russia, Saudi Arabia, Singapore,Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan ROC, Turkey, United Kingdom, Uruguay and Venezuela. EXPANDED RECALL additional countries include: China, Croatia, Korea. Lithuania, Madagascar, Maldives, Malta, Monaco, Nepal and Thailand.

Lot, serial or model codes

Affected devices may be contained in the following serial number ranges.  Model 476: INITIAL RECALL serial numbers 103316 thru 106064. EXPANDED RECALL serial numbers 102072 thru 108200. Model 976: INITIAL RECALL serial numbers 202612 thru 205357. EXPANDED RECALL serial numbers 201909 thru 206416.  Model 1176: INITIAL RECALL serial numbers 303330 thru 306689. EXPANDED RECALL serial numbers 301600 thru 307991 and  Model 1276: INITIAL RECALL serial numbers 404640 thru 409060. EXPANDED RECALL serial numbers 401743 thru 411144.

510(k) numbers

not on file

PMA numbers

["P940031"]

Product code

LWP

Firm FEI

2124215

Firm city

Saint Paul

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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