CLASS II Device recall · Reported 3 Jul 2013 · FDA Enforcement Report
TRUE Dilatation Balloon Valvuloplasty Catheter recalled
Loma Vista Medical is recalling TRUE Dilatation Balloon Valvuloplasty Catheter, distributed in New Jersey. The recall was initiated on 18 Mar 2013 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-1566-2013
- FDA event ID
- 65343
- Recalling firm
- Loma Vista Medical, Burlingame, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Mar 2013
- FDA classified
- 21 Jun 2013
- Reported
- 3 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 18 Mar 2013 | Recall initiated by company | |
| 21 Jun 2013 | Classified by FDA | +95 days |
| 3 Jul 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution-US Distribution in New Jersey and the countries of Germany, Switzerland, Italy, Norway, The Netherlands, Spain, Portugal, Ireland, and Austria.
Questions about this recall
Why was it recalled?
Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum.
Which lots are affected?
All lot numbers lower than PLN00749 are subject to this recall.
Where was it sold?
Worldwide Distribution-US Distribution in New Jersey and the countries of Germany, Switzerland, Italy, Norway, The Netherlands, Spain, Portugal, Ireland, and Austria.
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 26 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
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | 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 | 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 |