—#77501

Product

PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System. PROSTIVA RF Therapy Kit 8929, Sterilized using ethylene oxide, Manufacturer Medtronic Inc Minneapolis, MN 55432-5604, Manufactured at Medtronic, Inc Villalba, Puerto Rico. Indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 cm3 and 50 cm3.

FDA product code: KNS — Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K052413
Affected lot / code info: All lot numbers are included.

Why it was recalled

Reported incidents of needle retraction failure when using the PROSTIVA RF Model 8929 Hand Piece. The Medtronic Prostiva RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System.

Root cause (FDA determination)

Device Design

Action the firm took

A Medtronic "Urgent Medical Device Correction" letter addressed to "Healthcare Provider" was sent August 6, 2008. The letter described the issue, product involved and the Prostiva hand piece Disassembly Procedure that should be followed in the event the user is unable to retract the needles during a procedure. The letter also requested the return of the "Medtronic Reply Form/receipt Confirmation" form.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 800 53rd Ave NE PO Box 1250, Minneapolis, Minnesota 55440-1250

Distribution

Distribution pattern: Worldwide Distribution -- AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, RI, SC, SD, IN, TX, UT, VA, VT, WA, WI, WY, and WV and countries of Australia, New Zealand, China, Austria, Denmark, Finland, France, Germany, Italy, Kuwait, Lebanon, Norway, Qatar, Russian Federation, Spain, Sweden, Switzerland, and United Kingdom.

Timeline

Recall initiated: 2008-06-05
Posted by FDA: 2009-03-10
Terminated: 2012-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #77501. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.