TRUE Dilatation Balloon Valvuloplasty Catheter — Class II medical device recall Z-1566-2013
Terminated recall by Loma Vista Medical, reported 2013-07-03, distributed in NJ. Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normall
| Recall number | Z-1566-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Loma Vista Medical, Burlingame, CA, United States |
| Recall initiated | 2013-03-18 |
| Classified | 2013-06-21 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2013-07-17 |
| Distributed | NJ |
| Countries outside the US | AT, CH, DE, ES, IE, IT, NL, NO, PT |
| Quantity | 2,379 units |
| Model numbers | 02045-11, 02245-12, 02445-12, 02645-13 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1566-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.