FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
- Recall number
- Z-2327-2021
- Recalling firm
- Boston Scientific Corporation
- Product
- TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
- Status
- Open, Classified
- Initiated
- 2021-07-23
- Posted
- 2021-08-19
- Terminated
- not on file
- Reason
- Potential for leaks and loosening at the patient catheter connection
- 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
- 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.
- Lot, serial or model codes
- GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E
- 510(k) numbers
- not on file
- PMA numbers
- ["P200029"]
- Product code
- NAW
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28