Z-1404-2010

Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA

Name: Z-1404-2010 Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA
Creator: Novasys Medical Inc
Published: 2009-07-27
License: https://open.fda.gov/license/

Novasys Medical, Inc. / initiated 2009-07-27 / Terminated / root cause: labeling and UDI

FDA source

Novasys Medical Inc began a recall of Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA on 2009-07-27. The reason FDA records is "Instructions for Use (IFU) revision-- Because of complaints received by the firm of worsened stress incontinence symptoms 3-4 weeks after treatment, the instructions for use were revised to emphasize potential side...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1404-2010
Status: Terminated
Initiated: 2009-07-27
Posted: 2010-04-16
Terminated: 2011-01-08
Recalling firm: Novasys Medical, Inc.
Product: Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA
Product code: NVJ Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
Reason for recall: Instructions for Use (IFU) revision-- Because of complaints received by the firm of worsened stress incontinence symptoms 3-4 weeks after treatment, the instructions for use were revised to emphasize potential side effects. Although Novasys has not, to date, identified a device malfunction associated with the symptoms discussed above, the investigation over time shows that there is a correlation
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: A Field Action notification letter was sent to all current customers (physicians) along with the revised instructions for use, and a small supply of the revised patient information brochures. The company also updated physician information brochures and patient/physician DVDs to include the information. This was shipped to physicians in August/September of 2009. Additional copies of the Patient Brochures can be ordered by contacting Novasys Customer Service at 866-784-4777. Questions should be addressed to the firm at the same telephone number.
Quantity in commerce: As of 6/12/09 there were 436 Probes at customer accounts.
Distribution: US nationwide only. (TX, FL, CA, LA, KY, MO, GA,OR WA, HI, AZ, OK AL, TN) .
Product codes and lots: Issue affects all lots in distribution.

Product code NVJ

K042132Class IINovasys Transurethral RF SystemNovasys Medical, Inc. / cleared 2004-12-21

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)