FDA Medical Device Recalls (openFDA)
InterValve Inc: InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
- Recall number
- Z-1621-2014
- Recalling firm
- InterValve Inc
- Product
- InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
- Status
- Terminated
- Initiated
- 2014-03-14
- Posted
- 2014-05-15
- Terminated
- 2014-06-16
- Reason
- Leak issues were discovered through accelerated age testing.
- Root cause
- Nonconforming Material/Component
- Action
- Since this recall involved only 2 units at one site, the devices were picked up by the sales representative. There was no written communication regarding this. The site was verbally informed that there was a problem with the device that manifests itself during prepping and the devices need to be retrieved for retest.
- Quantity
- 2
- Distribution
- Distribution to TN only
- Lot, serial or model codes
- Lot numbers: 101637, 101640
- 510(k) numbers
- ["K133607"]
- PMA numbers
- not on file
- Product code
- OZT
- Firm FEI
- 3010133561
- Firm city
- Minnetonka
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28