Food, drugs, devices › Abbott Medical
Device recall: Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Abbott Medical (Plano, TX) initiated this device recall on 22 May 2024; FDA lists 4 product records under event 94796, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Abbott Medical has 16 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Abbott Medical, Plano, TX.
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."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2429-2024 | Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only | 5,900 units | Class II | Ongoing | 31 Jul 2024 |
| Z-2430-2024 | Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only | 5,900 units | Class II | Ongoing | 31 Jul 2024 |
| Z-2431-2024 | Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only | 20,790 units | Class II | Ongoing | 31 Jul 2024 |
| Z-2432-2024 | Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only | 1198 units | Class II | Ongoing | 31 Jul 2024 |
Context
Other enforcement events for Abbott Medical
All 16 events for Abbott Medical
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.