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U.S. Department of Health and Human Services

Class 2 Device Recall Finesse BTK Multicath

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 Class 2 Device Recall Finesse BTK Multicathsee related information
Date Initiated by FirmJuly 21, 2025
Date PostedMarch 30, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1704-2026
Recall Event ID 98493
510(K)NumberK230263 K241740 
Product Classification Catheter, angioplasty, peripheral, transluminal - Product Code LIT
ProductBrand 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
Code Information Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;
FEI Number 3027395815
Recalling Firm/
Manufacturer		 SUMMA THERAPEUTICS, LLC
119 Braintree St Ste 508
Allston MA 02134-1851
For Additional Information ContactTimothy Murphy, M.D.
877-2672685
Manufacturer Reason
for Recall		Potential for the balloon in the device to not meet burst specifications.
FDA Determined
Cause 2		Process control
ActionOn 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 Commerce22 units
DistributionUS Nationwide distribution in the states of New Jersey, Florida.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LIT
510(K)s with Product Code = LIT
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