Z-1566-2013Class II

TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13...

Name: Z-1566-2013 TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13...
Creator: Loma Vista Medical
Published: 2013-03-18
License: https://open.fda.gov/license/

Loma Vista Medical / initiated 2013-03-18 / Terminated / root cause: manufacturing process

FDA source

Loma Vista Medical began a recall of 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... on 2013-03-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1566-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-18
Posted: 2013-06-21
Terminated: 2013-07-17
Recalling firm: Loma Vista Medical
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.
Product code: OZT 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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm sent an "URGENT VOLUNTARY DEVICE REMOVAL" letter dated March 18, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in commerce: 2379 units
Distribution: Worldwide Distribution-US Distribution in New Jersey and the countries of Germany, Switzerland, Italy, Norway, The Netherlands, Spain, Portugal, Ireland, and Austria.
Product codes and lots: All lot numbers lower than PLN00749 are subject to this recall.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1566-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1566-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-21

Product code OZT

K121083Class IITrue Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20Mm X 4.5Cm, True Dilatation Percutaneous TransluminaLoma Vista Medical / cleared 2012-10-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)