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U.S. Department of Health and Human Services

Class 2 Device Recall PROSTIVA RF Model 8929 Hand Piece

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 Class 2 Device Recall PROSTIVA RF Model 8929 Hand Piecesee related information
Date Initiated by FirmJune 05, 2008
Date PostedMarch 10, 2009
Recall Status1 Terminated 3 on May 17, 2012
Recall NumberZ-1060-2009
Recall Event ID 50856
510(K)NumberK052413 
Product Classification Endoscopic Electrosurgical Unit - Product Code KNS
ProductPROSTIVA 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.
Code Information All lot numbers are included.
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
For Additional Information Contact
763-514-5174
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionA 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 in Commerce40,168
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KNS
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