Boston Scientific Corporation: Medical Device Recall in 2024 - (Recall #: Z-1672-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter

Product Classification:

Class I

Date Initiated: March 21, 2024

Date Posted: May 22, 2024

Recall Number: Z-1672-2024

Event ID: 94240

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.

Status: Ongoing

Product Quantity: 23529 catheters

Code Information:

UDI/DI 08714729249412, Batch Numbers: 60437054, 60447182, 60463964, 60477273, 60488498, 60495556, 60437063, 60447183, 60465472, 60481568, 60488499, 60497690, 60437064, 60448980, 60465473, 60483603, 60488500, 60507240, 60438200, 60448981, 60465481, 60483604, 60490167, 60507657, 60438201, 60448982, 60465482, 60483634, 60490169, 60507658, 60438202, 60454958, 60465483, 60483635, 60490170, 60507659, 60445390, 60460144, 60474107, 60483638, 60490171, 60517310, 60447181, 60463963, 60474501, 60488390, 60491660, 60517311, 60488497, 60491661, 60530050, 60495555, 60538219

Distribution Pattern:

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Voluntary or Mandated:

Voluntary: Firm initiated