Recall Z-1060-2009 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Medtronic Neuromodulation
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) i
| Date | Mar 10, 2009 (initiated Jun 5, 2008) |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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. |
| Quantity | 40,168 |
| Distribution | 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, Fran |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052413 | TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 Medtronic Vascular, Nov 17, 2005 |