CLASS II Device recall · Reported 21 May 2014 · FDA Enforcement Report
V8 Balloon Aortic Valvuloplasty Catheter recalled by InterValve
InterValve is recalling InterValve V8 Balloon Aortic Valvuloplasty Catheter, distributed in Tennessee. The recall was initiated on 14 Mar 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1621-2014
- FDA event ID
- 67964
- Recalling firm
- InterValve, Minnetonka, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Mar 2014
- FDA classified
- 15 May 2014
- Reported
- 21 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 14 Mar 2014 | Recall initiated by company | |
| 15 May 2014 | Classified by FDA | +62 days |
| 21 May 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Leak issues were discovered through accelerated age testing.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Where it was distributed
Distribution to TN only
Questions about this recall
Is V8 Balloon Aortic Valvuloplasty Catheter recalled?
Yes. InterValve recalled V8 Balloon Aortic Valvuloplasty Catheter on 14 Mar 2014. The recall is Class II and its status is Terminated. Recall number Z-1621-2014.
Why was it recalled?
Leak issues were discovered through accelerated age testing.
Which lots are affected?
Lot numbers: 101637, 101640
Where was it sold?
Distribution to TN only
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |