Recalls / —

—#188522

Product

TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)

FDA product code

NAW — Microspheres Radionuclide

Device class

Class 3

Medical specialty

Unknown

PMA numbers

P200029

Affected lot / code info

GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E

Why it was recalled

Potential for leaks and loosening at the patient catheter connection

Root cause (FDA determination)

Component change control

Action the firm took

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.

Recalling firm

Firm

Boston Scientific Corporation

Address

1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

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.

Timeline

Recall initiated

2021-07-23

Posted by FDA

2021-08-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #188522. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.