FDA Medical Device Recalls (openFDA)
Boston Scientific CRM Corp: CONTACT RENEWAL 3 AVT model numbers M150 and M155; CONTACT RENEWAL 3 AVT HE model numbers M157 and M159; CONTACT RENEWAL 4 AVT model numbers M170 and M175; CONTACT RENEWAL 4 AVT HE model numbers M177 and M179. Cardiac Resynchronization Therapy Defibrillator. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. CONTAK RENEWAK AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.
- Recall number
- Z-0956-05
- Recalling firm
- Boston Scientific CRM Corp
- Product
- CONTACT RENEWAL 3 AVT model numbers M150 and M155; CONTACT RENEWAL 3 AVT HE model numbers M157 and M159; CONTACT RENEWAL 4 AVT model numbers M170 and M175; CONTACT RENEWAL 4 AVT HE model numbers M177 and M179. Cardiac Resynchronization Therapy Defibrillator. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. CONTAK RENEWAK AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.
- Status
- Terminated
- Initiated
- 2005-06-17
- Posted
- 2005-06-30
- Terminated
- 2008-03-02
- Reason
- The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy.
- Root cause
- Other
- Action
- Firm issued a Dr. Doctor letter dated 06/17/05. Letter informs physicians of the issue, clinical implications, recommendations and action taken by the firm.
- Quantity
- 2,204 devices (786 remain implanted worldwide)
- Distribution
- worldwide. To the US and OUS countries to include: Argentina, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Syrian Arab Republic, Turkey, US - Virgin Islands and United Kingdom.
- Lot, serial or model codes
- all serial numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- 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