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Expo™ H749085262011Recalls & reported problems

Boston Scientific Corporation · Angiographic Catheter · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Mar 21, 2024Open, Classified

    An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

    Z-1649-2024 · Root cause: Under Investigation by firm · FDA record ↗

Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices

All CATHETER, INTRAVASCULAR, DIAGNOSTIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.