Boston Scientific recalls TheraSphere Administration Set model 990226.SPE due to potential leaks and loosening at patient catheter connection. Affected units include specific lot numbers and GTIN.
Potential for leaks and loosening at the patient catheter connection
Boston Scientific is recalling TheraSphere Administration Sets with model number 990226.SPE because they may leak or loosen at the patient catheter connection. This could lead to complications during medical procedures if not fixed.
The device may leak or loosen at the patient catheter connection during use, which could cause improper delivery of radiation therapy or other medical complications. This risk is specific to the connection point where the device interfaces with the patient's body.
Patients using this medical device for procedures like radiation therapy are most at risk. Healthcare providers who handle the device during treatments may also be affected.
Check for the model number 990226.SPE on the device. Affected units include specific lot numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E. The GTIN is 05060116920253.
Look for the model number 990226.SPE on the TheraSphere Administration Set.
Reach out to Boston Scientific Corporation for further instructions on handling the device.
The model number is 990226.SPE.
Affected lot numbers include 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, and 692E.
Check for the model number 990226.SPE and the affected lot numbers listed in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2327-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2327-2021 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
