Loma Vista Medical Recalls TRUE Dilatation Balloon Valvuloplasty Catheters
Loma Vista Medical is recalling TRUE Dilatation Balloon Valvuloplasty Catheters because they deflate slower than the specified maximum of 10 seconds.
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: The recall involves a high-risk medical device where a performance defect (slow deflation) poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Loma Vista Medical is recalling 2,379 units of the TRUE Dilatation Balloon Valvuloplasty Catheter. The affected reference numbers are 02045-11, 02245-12, 02445-12, and 02645-13, with sizes ranging from 20mm x 4.5cm to 26mm x 4.5cm. These devices are intended for use in balloon aortic valvuloplasty. The recall applies to all units with lot numbers lower than PLN00749.
The recall is due to a defect where the balloon deflates slower than normal. While the balloon normally deflates in less than 5 seconds, the device performance specification allows for a maximum deflation time of 10 seconds. The recalled units exhibit a deflation time greater than 10 seconds.
The affected products were distributed worldwide, including in the United States (New Jersey) and in Germany, Switzerland, Italy, Norway, The Netherlands, Spain, Portugal, Ireland, and Austria. Healthcare providers and facilities should stop using the affected catheters and contact Loma Vista Medical for instructions on returning the devices.
The recalled product
- Product
- TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.
- Manufacturer
- Loma Vista Medical
- Category
- Medical Device — Cardiovascular
- Affected units
- 2,379
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 (1)
- All lot numbers lower than PLN00749 are subject to this recall.
Distribution
Distributed in 1 state:
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