FDA Device Recall Z-1646-2024
Boston Scientific Corporation · Maple Grove, MN
Class I — life-threatening Ongoing
Device
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter
Reason for recall
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.
Recall record
- Recall number
Z-1646-2024- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
- Recall initiated
- 2024-03-21
- Classified by FDA Center
- 2024-05-10
- FDA published
- 2024-05-22
- Recalling firm
- Boston Scientific Corporation
- Firm location
- Maple Grove, MN
Operational response
A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.
For the official FDA enforcement record, see FDA's Recall Search.