Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage
Boston Scientific is recalling Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect (breakage) in a medical device used for drainage, which poses a significant risk of injury.
Plain-English summary
Boston Scientific Corporation is recalling Malecot Nephrostomy Catheter Sets, Product Number M0064101000, GTIN 08714729005261. The recall involves 1,480 units distributed worldwide, including the United States and numerous international locations.
The recall was initiated because certain catheters are breaking at the mid-shaft bond during use. The affected products have expiration dates ranging from January 22, 2018, to October 24, 2021, and include specific batch numbers listed in the agency's records.
Healthcare providers and patients should stop using the affected catheters and contact Boston Scientific for further instructions.
The recalled product
- Product
- Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography "…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,480
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 (1)
- Expiration Date Range: 1/22/2018 - 10/24/2021
Distribution
Part of a larger recall action
This product is one of 6 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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