Boston Scientific HYDRATOME RX Device Recalled Due to Sterile Barrier Breach
Boston Scientific is recalling 7,695 units of HYDRATOME RX devices worldwide due to compromised sterility from a sterile barrier breach. Affected devices may pose a risk of infection.
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 no reported illnesses or injuries. The sterile barrier breach represents a risk-of-harm situation in a medical device that must remain sterile, which per the rubric qualifies as 3 (High) when injury has not been reported.
Plain-English summary
Boston Scientific Corporation is recalling 7,695 units of the HYDRATOME RX 44-20MM/260CM medical device. These devices have been distributed worldwide, including the United States and numerous countries internationally.
The recall is due to a sterile barrier breach that compromises the sterility of the devices. Devices with a compromised sterile barrier may pose a risk of contamination or infection.
Healthcare facilities and providers who have received affected units should identify inventory using the following lot numbers: 27439836, 27440919, 27493069, 27496980, 27499896, 27750785, 27753215, 27825981, 27879216, 27880741, 27931764, 27934862, 28032489, and 28043447. Contact Boston Scientific Corporation immediately for instructions regarding device return and replacement.
The recalled product
- Product
- HYDRATOME RX 44-20MM/260CM Material Number: M00583040
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 7,695
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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