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U.S. Department of Health and Human Services

Class 2 Device Recall Infinity 5, Implantable Pulse Generator

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 Class 2 Device Recall Infinity 5, Implantable Pulse Generatorsee related information
Date Initiated by FirmMay 22, 2024
Date PostedJuly 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2429-2024
Recall Event ID 94796
Product Classification Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
ProductAbbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Code Information All Serial numbers/UDI:05415067030016/05415067020246
FEI Number 1627487
Recalling Firm/
Manufacturer		 Abbott Medical
6901 Preston Rd
Plano TX 75024-2508
For Additional Information ContactCarolina Castano
512-286-4021
Manufacturer Reason
for Recall		Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
FDA Determined
Cause 2		Error in labeling
ActionOn June 6, 2024, Abbott, issued a "Urgent Medical Device Correction" notification to affected consignees via mail. Abbott asked consignees to take the following actions: 1. This issue will continue to affect your patients for the foreseeable future. Abbott is working on an update to align the product labeling with actual device performance. 2. For information on when an ERI notification appears and how to make a determination with your patients on timing of IPG replacement, see the customer communication. 3. For recommended strategies for preventing lapse in therapy, see the customer communication. 4. Please inform your patients about this medical device correction letter. 5. Please return a completed Acknowledgement Form and maintain a record of this notice along with a copy of the completed Acknowledgement Form. 6. For questions about this issue or reported complaints, please contact your Abbott representative, or Abbott Technical Support at 1-800-727-7846. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in Commerce5,900 units
DistributionWorldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, WA, WI, WY and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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