Exact FDA event identifier

Event 98493

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: July 21, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: SUMMA THERAPEUTICS, LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1704-2026

Recall number: Z-1704-2026
Initiated: July 21, 2025
Classification: Class II
Status: Ongoing
Recalling firm: SUMMA THERAPEUTICS, LLC
Quantity: 22 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for the balloon in the device to not meet burst specifications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for the balloon in the device to not meet burst specifications.

Code information

Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;

Distribution pattern

US Nationwide distribution in the states of New Jersey, Florida.