FDA Device recall Z-1566-2013
TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13
- FDA Device
- Class II
- terminated
- Published 2013-07-03
On 2013-07-03 the FDA classified a Class II recall of TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13 by Loma Vista Medical, citing 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 specificati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1566-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-18 |
| Published | 2013-07-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Loma Vista Medical |
| Distribution | NJ |
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
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.
Identifiers
| code_info | All lot numbers lower than PLN00749 are subject to this recall. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1566-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.