FDA Medical Device Recalls (openFDA)
Guidant Corporation: VIRTUS PLUS II (model nos. 1380 and 1480) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . VIRTUS PLUS II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available; these adapt the pacing rate to the patient's changing metabolic demand.
- Recall number
- Z-1037-05
- Recalling firm
- Guidant Corporation
- Product
- VIRTUS PLUS II (model nos. 1380 and 1480) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . VIRTUS PLUS II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available; these adapt the pacing rate to the patient's changing metabolic demand.
- 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
- 94
- 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 1380: serial numbers 100000 thru 100044. Model 1480: Serial numbers 500005 thru 500072.
- 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
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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