Reported Jul 17, 2013 · Terminated
NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140,…
Boston Scientific Corporation
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: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- NephroMax high Pressure Nephrostomy Balloon Catheter
- Material Number/Catalog NumberM0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract
- Lot codes and dates
- Lot Number
158758611587586015875299158727971587279915872798
- Lot Number
- Amount recalled
- 27
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
Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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