PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System. PROSTIVA RF Therap
FDA device recall Z-1060-2009 · posted 2009-03-10 · Terminated
Recall details
- Recalling firm
- Medtronic Neuromodulation
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KNS
- Quantity affected
- 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
- Date initiated
- 2008-06-05
- Date posted
- 2009-03-10
- Date terminated
- 2012-05-17
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 (K052413) | Medtronic Vascular | 2005-11-17 |