Reported Aug 26, 2026 · Ongoing · Updated Sep 16, 2026
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Boston Scientific Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
- Lot codes and dates
- GTIN 00811311020829
- Lot Numbers
327 of 327 codes
200832200850201057201070201087201113201128201143201157201177201190201220201235201312201333201351201379201407201422201487300015300028300043300058300075300099300114300135300143300154300168300188300203300213300229300252300262300271300311300325300346300358300377300395300404300418300430300445300471300492300520300532300545300559300566300581300600300613300630300664
- Amount recalled
- 115,458 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Potential for arterial sheath tip separation or partial tip separation during use.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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