Reported Dec 18, 2019 · Ongoing
Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
Medtronic Navigation, Inc.
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: Medtronic Navigation, Inc. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
- Passive Biopsy Needle Kit
- UDI00643169030121 and 00643169702943
- Lot codes and dates
- Lot Numbers
66503918A066513519A066529218A066535518A66503919066513519C66531018066512319A066513519E066531018A066512319C6652921866535518
- Lot Numbers
- Amount recalled
- 10,448 disposable biopsy needles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.
This product could cause temporary or reversible health problems — stop using it.
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