FDA Recall of Finesse BTK Multicath by SUMMA THERAPEUTICS
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SUMMA THERAPEUTICS, LLC is recalling 22 units of the Finesse BTK Multicath due to potential issues with the balloon not meeting burst specifications, affecting devices distributed nationwide.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 16, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
SUMMA THERAPEUTICS, LLC is voluntarily recalling their Finesse BTK Multicath, an injectable angioplasty balloon catheter, because of a potential for the balloon in the device to not meet burst specifications.
Which Products Are Affected
The affected product is the Finesse BTK Multicath, with model/catalog number FS252251502. It is described as a 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, with a balloon diameter of 2.5mm, balloon length of 225mm, and catheter working length of 150cm. The recall involves 22 units, with UDI-DI: 00810017490967 and lots: 240502, 240095, 231296, 231296A, and 240095A. Distribution occurred nationwide in the United States, specifically in the states of New Jersey and Florida. The recall number is Z-1704-2026.
What You Should Do
Consumers should contact SUMMA THERAPEUTICS, LLC at their address: 119 Braintree St Ste 508, Allston, MA 02134-1851, as the initial notification was made via letter. Follow the firm's instructions for returns or refunds related to this recall.
Why This Matters
This recall addresses a potential safety defect in a medical device that could impact its performance during procedures, highlighting the importance of ensuring device reliability in healthcare settings.
Source
Attribution: FDA Recall Number Z-1704-2026. For more information, visit the FDA website at the appropriate recall page (source data reference).
Original source: FDA Official Notice ↗
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