Reported Jul 24, 2024 · Ongoing
Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, 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 Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only
- Lot codes and dates
- UDI05415067020208/ All Serial Numbers
- Amount recalled
- 1379 units
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
Why it was recalled
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
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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