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U.S. Department of Health and Human Services

Class 2 Device Recall TheraSphere

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  Class 2 Device Recall TheraSphere see related information
Date Initiated by Firm July 23, 2021
Date Posted August 19, 2021
Recall Status1 Open3, Classified
Recall Number Z-2327-2021
Recall Event ID 88369
PMA Number P200029 
Product Classification Microspheres radionuclide - Product Code NAW
Product TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Code Information GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Rebecca KinKead Rubio
763-494-1133
Manufacturer Reason
for Recall		 Potential for leaks and loosening at the patient catheter connection
FDA Determined
Cause 2		 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 4980 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = NAW and Original Applicant = Boston Scientific Corporation
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