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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic Micro Jewel

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 Class 1 Device Recall Medtronic Micro Jewelsee related information
Date Initiated by FirmApril 02, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on November 29, 2005
Recall NumberZ-0811-04
Recall Event ID 28798
PMA NumberP900061/S24 
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
ProductMedtronic Micro Jewel II Implantable Cardioverter Defibrillators, Model 7223Cx
Code Information Manufacturing dates from November 1996 to December 1997; and   Use Before Dates from May 1998 to June 1999. 
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Managment
7000 Central Ave N.E.
Fridley MN 55432
For Additional Information ContactTim Samsel
763-514-3149
Manufacturer Reason
for Recall		Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected charge circuit time-outs or charge circuit inactive conditions as the battery voltage nears the level for Elective Replacement of the devices.
FDA Determined
Cause 2		Other
ActionA letter, dated April 2004, was sent on April 5, 2004 to physicians following patients who had the defibrillators implanted. The letter gave recommendations to physicians for selective replacement of some of the implanted devices and for avoiding the problem. Physicians are being visited by sales representatives to verify notification.
Quantity in Commerce5839 units (2394 units in the United States)
DistributionNationwide in the United States and worldwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = LWS
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