Z-2429-2024Class II

Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only

Name: Z-2429-2024 Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Creator: Abbott Medical
Published: 2024-05-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-05-22 / Open, Classified / root cause: labeling and UDI

FDA source

Abbott Medical began a recall of Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only on 2024-05-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2429-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-22
Posted: 2024-07-25
Recalling firm: Abbott Medical
Product: Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 5,900 units
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 codes and lots: All Serial numbers/UDI:05415067030016/05415067020246

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2429-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2429-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-25
Z-2430-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-25
Z-2431-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-25
Z-2432-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-25

Product code MHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)