Sterile barrier breach recalled in Boston Scientific HYDRATOME RX catheters
Boston Scientific is recalling HYDRATOME RX catheters due to sterile barrier compromise. The 112 affected units worldwide may pose infection risk if used.
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: FDA Class II recall with sterile barrier compromise in a medical device. No illnesses or injuries have been reported, but the breach creates a theoretical risk of infection if the device is used, meeting the rubric criterion for high-risk products without reported harm.
Plain-English summary
Boston Scientific Corporation is recalling HYDRATOME RX 49-20MM/260CM medical devices (Material Number M00583000) due to a sterile barrier breach that compromises device sterility.
A total of 112 units were distributed worldwide, including to the United States and 34+ countries across Europe, Asia, Africa, and Oceania. The affected lot numbers are 27852433 and 28028722 (GTIN: 8714729755159).
The compromised sterility creates a risk of infection if the affected devices are used. This Class II recall addresses the potential hazard posed by non-sterile medical devices in procedural applications.
The recalled product
- Product
- HYDRATOME RX 49-20MM/260CM Material Number: M00583000
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 112
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)
- Lot Numbers: 27852433 28028722 GTIN: 8714729755159
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 31 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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