UroMax Ultra kits recalled over particles migrating from the inflation device
Boston Scientific UroMax Ultra Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 1,369 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; particles migrating into a catheter used inside the body is a potential harm and no injuries are reported.
Plain-English summary
Boston Scientific UroMax Ultra Kits are being recalled across material numbers including M0062251200, M0062251210, M0062251220, M0062251230, M0062251240, M0062251260, M0062251290, M0062251300, M0062251310 and M0062251350, with affected lot numbers listed per material number in the recall notice. The recall covers 1,369 units distributed worldwide.
The Encore 26 Inflation Device, supplied in the kit, is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate it. An internal investigation determined that during use, foreign material particles could migrate from affected devices into a balloon dilatation catheter. The FDA classified the action as Class II.
Hospitals holding these lots should quarantine them and follow the manufacturer's instructions for return or replacement.
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
- Affected units
- 1,369
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.
Part of a larger recall action
This product is one of 4 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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