Boston Scientific Recalls NephroMax Balloon Catheters Due to Incorrect Sheath Packaging
Boston Scientific is recalling 27 NephroMax high pressure nephrostomy balloon catheters because they were packaged with incorrectly sized renal sheaths.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a packaging error (incorrect sheath size) without reporting any illnesses, injuries, or fatalities, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Boston Scientific Corporation is recalling 27 units of the NephroMax high pressure nephrostomy balloon catheter. The recall was initiated because an incorrectly sized renal sheath was packaged with the device. The affected products are identified by Material Numbers M0062101400/210-140 and M062101440/210144, and Lot Numbers 15875861, 15875860, 15875299, 15872797, 15872799, and 15872798.
The affected devices were distributed worldwide, including nationwide in the United States (specifically in New Jersey, New York, Ohio, Illinois, Michigan, Maryland, and Massachusetts) and in Denmark, Great Britain, and Spain. The devices are used for the dilation of the nephrostomy tract.
Healthcare providers and consumers should stop using the affected devices and contact Boston Scientific Corporation for further instructions or a replacement.
The recalled product
- Product
- NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 27
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot Number: 15875861
- 15875860
- 15875299
- 15872797
- 15872799
- 15872798
Distribution
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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