InterValve V8 Balloon Aortic Valvuloplasty Catheter Recalled for Leak Issues
InterValve Inc is recalling specific V8 Balloon Aortic Valvuloplasty Catheters due to leak issues discovered during accelerated age testing.
What this means for you
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 is classified as FDA Class II and involves a medical device with a functional defect (leak) that poses a risk of harm, but no injuries or illnesses have been reported.
Plain-English summary
InterValve Inc is recalling specific units of the V8 Balloon Aortic Valvuloplasty Catheter. The affected models are 172212C110, 192412C110, 212612C110, and 232812C110. The recall involves two units with lot numbers 101637 and 101640.
The recall was initiated because leak issues were discovered through accelerated age testing. The agency has classified this recall as Class II.
The affected products were distributed to Tennessee only. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
- Manufacturer
- InterValve Inc
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 2
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 (2)
- Lot numbers: 101637
- 101640
Distribution
Distributed in 1 state:
Related recalls
Same hazard · leak
See all →- HighAVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
FDA (Devices) · 2026-08-26
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighAnti-siphon smallbore extension sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05