Boston Scientific Recalls NephroMax Balloon Catheter Kits Due to Packaging Error
Boston Scientific is recalling 15 NephroMax high pressure nephrostomy Balloon Catheter Kits because an incorrectly sized renal sheath was packaged with the device.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where the specific injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Boston Scientific Corporation is recalling 15 units of the NephroMax high Pressure nephrostomy Balloon Catheter Kit. The recall is due to a packaging error where an incorrectly sized renal sheath was included with the catheter. The affected products are identified by Material Numbers M0062101600/210-160 and M0062101640/210-164, and Lot Numbers 15982017, 15963887, and 16034014.
The recall is classified as Class II by the FDA. The products 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 products and contact Boston Scientific Corporation for further instructions or a replacement.
The recalled product
- Product
- NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheter
- Affected units
- 15
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 (3)
- Lot Number: 15982017
- 15963887
- 16034014
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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