Boston Scientific recalls TheraSphere Administration Set model 990264.SPE due to potential leaks and loosening at patient catheter connections. 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 990264.SPE because they may leak or loosen at the patient catheter connection. This could lead to improper medication delivery or other complications during medical procedures.
The device may leak or loosen at the patient catheter connection during use, which could cause improper medication delivery or other complications. This poses a risk of incorrect treatment outcomes or device malfunction.
Patients using this medical device for treatments like radiation therapy are most at risk. Healthcare providers who administer the device may also be affected.
Check for the model number 990264.SPE on the device. Affected units include specific lot numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176.
Look for the model number 990264.SPE on the TheraSphere Administration Set.
Reach out to Boston Scientific Corporation for further instructions on the recall.
The model number is 990264.SPE.
Affected lot numbers include 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, and 61732176.
The recall does not require immediate stop use; contact Boston Scientific for specific instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2328-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2328-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
