DeviceSignal · Recall classified
Boston Scientific Corporation
FDA classified a device recall on 2026-08-20 · Class I · Z-2978-2026
EventRecall classified
Effective2026-08-20
ClassificationClass I
On 2026-08-20 the FDA classified a device recall from Boston Scientific Corporation as Class I. Product: Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number…. Recall Z-2978-2026. The firm initiated it on 2026-07-09. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2978-2026
- Classification
- Class I
- Classified on
- 2026-08-20
- Initiated on
- 2026-07-09
- Firm
- Boston Scientific Corporation
- Reason
- Potential for arterial sheath tip separation or partial tip separation during use.
- Product
- Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2978-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
d22f9f74408a89cfc3d57e79b3f66483551cdc3e8d0d814cdb35adc0d420faae- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)