Boston Scientific JAGTOME RX Recalled for Sterile Barrier Breach
Boston Scientific is recalling 96 units of JAGTOME RX medical devices due to a sterile barrier breach that compromises device sterility. Patients should contact their physician if they received this 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: FDA Class II recall affecting a sterile medical device intended for patient use. Although no illnesses or injuries have been reported, the sterile barrier breach poses a direct risk of harm, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Boston Scientific Corporation is recalling 96 units of JAGTOME RX (Material Number M00573020, Lot Number 27571949) due to a sterile barrier breach that compromises the sterility of the device. These devices were distributed worldwide, including throughout the United States and to multiple countries including Australia, Austria, Belgium, Canada, China, France, Germany, Japan, and others.
The sterile barrier breach represents a manufacturing defect that may affect the sterility assurance of the recalled devices. Sterility is critical for medical devices, and a breach in the sterile barrier could potentially expose patients to contamination-related complications. As of this recall announcement, no illnesses or injuries related to this issue have been reported.
Patients who received this recalled device should contact their physician to determine if they may have been affected and to discuss appropriate follow-up care. Healthcare providers should review patient records to identify anyone who received this device (using Lot Number 27571949 or Material Number M00573020) and contact those patients to discuss next steps.
The recalled product
- Product
- JAGTOME RX 49-30-260-035 Material Number: M00573020
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 96
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: 27571949 GTIN: 8714729776734
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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