Boston Scientific UroMax Ultra Kit inflation devices recalled for foreign material contamination
Boston Scientific is recalling 1,369 UroMax Ultra Kit inflation devices worldwide due to potential migration of foreign material particles into balloon dilation catheters.
What this means for you
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 involving a functional defect in an invasive medical device with potential for patient harm from foreign material contamination. No illnesses, injuries, or hospitalizations have been reported, fitting the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 1,369 UroMax Ultra Kit inflation devices used in urological procedures to create, monitor, and deflate pressure in balloon dilation catheters.
An internal investigation determined that during use, foreign material particles could migrate from the inflation devices into the balloon dilation catheter. Affected devices were distributed worldwide and are identified by specific material numbers and lot numbers detailed in the FDA recall notice.
No illnesses or injuries have been reported. Healthcare providers should review the identified lot numbers and assess whether affected devices are currently in inventory.
The recalled product
- Product
- Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240, 6. M0062251260, 7. M0062251290, 8. M0062251300, 9. M0062251310. 10. M0062251350, 11. M0062251360, 12. M0062251370.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Urology
- Hazard
- foreign-material
- device-malfunction
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 (20)
- 1. M0062251200
- GTIN 8714729341277
- Lot Numbers: 35536688
- 35538633
- 35538634
- 35543803
- 35543804
- 35572728
- 35678100
- 2. M0062251210
- GTIN 8714729341284
- Lot Numbers: 35274797
- 35274799
- 35277223
- 35277224
- 35294475
- 35294476
- 35584203
- 35584215
- 35656798
Distribution
Distribution scope not specified by the agency.
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