CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report
Finesse BTK Multicath Injectable Angioplasty Balloon Catheter recalled
Summa Therapeutics is recalling Finesse BTK Multicath Injectable Angioplasty Balloon Catheter, distributed nationwide in the US. The recall was initiated on 21 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1704-2026
- FDA event ID
- 98493
- Recalling firm
- Summa Therapeutics, Allston, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jul 2025
- FDA classified
- 30 Mar 2026
- Reported
- 8 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 21 Jul 2025 | Recall initiated by company | |
| 30 Mar 2026 | Classified by FDA | +252 days |
| 8 Apr 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the balloon in the device to not meet burst specifications.
Product as listed by the FDA
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA
Where it was distributed
US Nationwide distribution in the states of New Jersey, Florida.
Questions about this recall
Why was it recalled?
Potential for the balloon in the device to not meet burst specifications.
Which lots are affected?
Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;
Where was it sold?
US Nationwide distribution in the states of New Jersey, Florida.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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