Z-2328-2021Class II

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

Name: Z-2328-2021 TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Creator: Boston Scientific Corporation
Published: 2021-07-23
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2021-07-23 / Open, Classified

FDA source

Boston Scientific Corporation began a recall of TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE) on 2021-07-23. FDA classified it as Class II and gives the reason as "Potential for leaks and loosening at the patient catheter connection". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2328-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-23
Posted: 2021-08-19
Recalling firm: Boston Scientific Corporation
Product: TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Product code: NAW Microspheres Radionuclide
Reason for recall: Potential for leaks and loosening at the patient catheter connection
FDA root cause: Component change control
Action: The firm disseminated a Medical Device Product Advisory on 07/23/2021 by overnight mail delivery. The letter explained the issue and directed users to ensure a firm connection is made between the outlet luer and the patient catheter prior to, and during ThersSphere administration.
Quantity in commerce: 4200 sets
Distribution: 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.
Product codes and lots: GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2328-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2327-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-19
Z-2328-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-19

Product code NAW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)