Boston Scientific Recalls Re-Entry Malecot Nephrostomy Catheter Sets
Boston Scientific is recalling specific Re-Entry 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 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 structural failure (breaking) of a medical device during use, which poses a risk of harm even though specific injuries are not detailed in the source text.
Plain-English summary
Boston Scientific Corporation is recalling 2,614 units of the Re-Entry Malecot Nephrostomy Catheter Set (Product Number: M0064101050). 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 14, 2018, to October 9, 2021, and include specific batch numbers listed in the agency's recall record. The devices were distributed nationwide in the United States, including the District of Columbia and Puerto Rico, as well as in numerous countries across the Americas, Asia, Europe, and Africa.
The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage for diagnostic and therapeutic indications, including antegrade pyelography and nephrostomy catheter drainage. Users should stop using the affected devices and contact Boston Scientific Corporation for further instructions.
The recalled product
- Product
- Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 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
- Hazard
- Affected units
- 2,614
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: 1/14/2018 - 10/9/2021
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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