Boston Scientific Corporation: Medical Device Recall in 2021 - (Recall #: Z-2328-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

Product Classification:

Class II

Date Initiated: July 23, 2021

Date Posted: August 25, 2021

Recall Number: Z-2328-2021

Event ID: 88369

Reason for Recall:

Potential for leaks and loosening at the patient catheter connection

Status: Ongoing

Product Quantity: 4200 sets

Code Information:

GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina.

Voluntary or Mandated:

Voluntary: Firm initiated