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Terminated

InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.

FDA Recall Z-1621-2014 · Posted 2014-05-15

Recalling FirmInterValve Inc
Recall StatusTerminated
Product CodeOZT
Date Initiated2014-03-14
Date Terminated2014-06-16
Product Quantity2

Reason for Recall

Leak issues were discovered through accelerated age testing.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distribution to TN only

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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