FDA Device Recall Z-1680-2024

Boston Scientific Corporation · Maple Grove, MN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter

Lot / serial / GTIN: UDI/DI 08714729187929, Batch Numbers: 60425143, 60448984, 60474111, 60482880, 60525062, 60427595, 60448985, 60477260, 60502674, 60530043, 60429297, 60463971, 60479435, 60511249, 60536205

Quantity: 11109 catheters

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-1680-2024
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.

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