Reported Jul 31, 2024 · Ongoing
Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
Abbott Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Medical · 6901 Preston Rd · Plano, TX · 75024-2508
Is this the product you have?
- Abbott Infinity 5, Implantable Pulse Generator
- REF6661, SterileEO, Rx Only
- Lot codes and dates
- All Serial numbers/UDI05415067020253
- Amount recalled
- 5,900 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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