Fines: Injectable Angioplasty Balloon Catheter Recall: Balloon May Not Meet Burst Specifications

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Contact the company & request your remedy

Recalling firmSUMMA THERAPEUTICS, LLC119 Braintree St Ste 508 · Allston, MA 02134-1851

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

SUMMA THERAPEUTICS is recalling Finesse BTK Multicath injectable angioplasty balloon catheters (model FS252251502) because the balloon may not meet burst specifications. This could lead to device failure during medical procedures, potentially causing injury to patients.

Why it’s dangerous

The balloon in the catheter may not withstand the pressure needed during medical procedures, potentially causing device failure. This could lead to complications such as bleeding or tissue damage during angioplasty treatments.

Who’s affected

Healthcare professionals using the catheter for angioplasty procedures are most at risk. Patients receiving the device during medical treatment may also be affected.

How to tell if you have this one

Check for model number FS252251502 on the catheter packaging or device. Affected units include specific production lots: 240502, 240095, 231296, 231296A, and 240095A.

Brand
Finesse BTK
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Number
Look for model number FS252251502 on the catheter packaging or device.

✎ GovInfoNow

Questions people ask

What is the model number of the recalled catheter?

The model number is FS252251502.

Which lots are affected?

Affected lots include 240502, 240095, 231296, 231296A, and 240095A.

Is there a remedy for this recall?

The recall record does not specify a remedy.

Take action

Contact Finesse BTK

We’ve drafted a message you can send Finesse BTK to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1704-2026 — Finesse BTK Finesse BTK

Hello,

I own a Finesse BTK that is covered by recall Z-1704-2026 from Finesse BTK.

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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Where this comes from

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.

Official source: FDA Recall #Z-1704-2026 (July 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1704-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

SUMMA THERAPEUTICS, LLC recalls Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number:

Recall notice