Finesse BTK angioplasty balloon catheter may not meet burst specifications
The Finesse BTK Multicath injectable angioplasty balloon catheter is being recalled because of the potential for the balloon not to meet burst specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a balloon that may not meet burst specifications is a hazard during an angioplasty procedure, and no injuries are stated.
Plain-English summary
The Finesse BTK Multicath Injectable Angioplasty Balloon Catheter, model FS252251502, is being recalled. The device is a 5 French sheath, 0.014 inch guidewire compatible over-the-wire injectable angioplasty balloon catheter with a 2.5 mm balloon diameter. About 22 units were distributed in New Jersey and Florida. The FDA has classified this recall as Class II.
There is potential for the balloon in the device to not meet burst specifications.
Affected product is identified by model number FS252251502.
Facilities can identify affected catheters by the model number above, and may contact the recalling firm for further information.
The recalled product
- 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…
- Manufacturer
- SUMMA THERAPEUTICS, LLC
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Model/Catalog Number: FS252251502
- UDI-DI: 00810017490967
- lots: 240502
- 240095
- 231296
- 231296A and 240095A
Distribution
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