Z-1704-2026Class II

Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number...

Name: Z-1704-2026 Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number...
Creator: Summa Therapeutics, Llc
Published: 2025-07-21
License: https://open.fda.gov/license/

Summa Therapeutics, LLC / initiated 2025-07-21 / Open, Classified / root cause: manufacturing process

FDA source

SUMMA THERAPEUTICS, LLC began a recall of Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath... on 2025-07-21. FDA classified it as Class II and gives the reason as "Potential for the balloon in the device to not meet burst specifications". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1704-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-21
Posted: 2026-03-30
Recalling firm: Summa Therapeutics, LLC
Product: 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
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: Potential for the balloon in the device to not meet burst specifications.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On July 21, 2025, customers were notified via E-mail. We discovered that the burst test values recorded did not meet the specification of the safety rated burst test average of 17atm. Please review your inventory and we ask that these catheters be returned for further investigation.
Quantity in commerce: 22 units
Distribution: US Nationwide distribution in the states of New Jersey, Florida.
Product codes and lots: Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1704-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1704-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-30

Product code LIT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)