CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL 4 RF (models H230, H
FDA device recall Z-0863-06 · posted 2006-05-16 · Terminated
Recall details
- Recalling firm
- Guidant Corporation
- Reason for recall
- Guidant received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted.
- Action taken
- Affected physicians were sent an Urgent Medical Device Safety Information & Corrective Action letter, dated 05/11/06. A press release was issued March 13, 2006 The letter describes the issue and emphasizes the importance of checking battery voltage prior to implant as stated in device labeling. For implanted devices, continue normal follow-up.
- Root cause
- Other
- Status
- Terminated
- Product code
- NIK
- Quantity affected
- 8,879
- Distribution
- Nationwide, Puerto Rico, Virgin Islands and to countries that include: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iran, Ireland, Israel, Italy, Luxembourg, Mexico, Ne
- Date initiated
- 2006-03-11
- Date posted
- 2006-05-16
- Date terminated
- 2006-12-31
- Location
- Saint Paul, MN
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