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Infinity recallZ-2431-2024 · Abbott Medical · initiated May 22, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Error in labeling

What the company is doing

On 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.

Recall details

Recall number
Z-2431-2024
Status
Open, Classified
Initiated by the company
May 22, 2024
Posted by the FDA
Jul 25, 2024
Recalling firm
Abbott Medical
Quantity
20,790 units
Product code
MHY
Distribution
Worldwide - 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.

Product description

Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only

Code information (models, lots, serial numbers)

All Serial numbers/UDI: 05415067030023 and 05415067020260

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94796).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page