System, Applicator, Radionuclide, Manual
Radiology · 21 CFR 892.5650
Recent MDR events
164 adverse event reports on file
- DELIVERY SETJul 7, 2026MalfunctionSirtex Medical, Inc.9710358-2026-00018
- SIROS D-VIAL PREP SETMay 26, 2026MalfunctionSirtex Medical, Inc.3005579300-2026-00001
- SIROS D-VIAL PREP SETApr 23, 2026MalfunctionSirtex Medical, Inc.9710358-2026-00012
- SIROS D-VIAL PREP SETJan 9, 2026MalfunctionSirtex Medical, Inc.3009088444-2026-00001
- SYSTEM, APPLICATOR, RADIONUCLIDE, MANUALJan 2, 2026MalfunctionCivco Medical Instruments Co., Inc.MW5181568
- PROSTATE STABILIZATION SET 18GA X 20CMNov 30, 2025InjuryArgon Medical Devices0001625425-2025-01148
- SIROS DELIVERY SETNov 4, 2025MalfunctionSirtex Medical Pty Limited9710358-2025-00016
- SIROS D-VIAL PREP SETOct 24, 2025MalfunctionSirtex Medical Pty Limited9710358-2025-00014
- BRACHY IMPLANT NEEDLESAug 25, 2025MalfunctionBard Brachytherapy, Inc. -14245261018233-2025-06994
- BRACHY IMPLANT NEEDLESAug 25, 2025MalfunctionBard Brachytherapy, Inc. -14245261018233-2025-06993
Event type breakdown
Recalls
11 recall events for this product code
- Sirtex Medical LimitedTerminatedMar 18, 2021
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
There is a potential presence of particulate matter in the D-Vial.
Z-1275-2021 · View FDA record ↗ - Riverpoint Medical, LLCTerminatedJan 10, 2020
Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR.
The integrity of the sterile grid packaging is potentially compromised.
Z-0795-2020 · View FDA record ↗ - Worldwide Medical Technologies, LLCTerminatedOct 12, 2011
Prostrate Seeding Applicator Needle. Product code PSS1820AT
Length of the cannula hub is longer and may not permit a fit with the Applicator
Z-0040-2012 · View FDA record ↗ - Medical Device Technologies, Inc.TerminatedJul 13, 2010
Angiotech Prostate Stabilization Set.
Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Access Needles, Galactography Kit, Stabilization Needles and Needle Guides for packaging integrity.
Z-2022-2010 · View FDA record ↗ - Alpha Omega Services IncTerminatedOct 22, 2008
Alpha-Omega Services, Inc. Product No: NFV0001-004
There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids.
Z-0166-2009 · View FDA record ↗ - Alpha Omega Services IncTerminatedOct 22, 2008
Alpha-Omega Services, Inc. Product No: NFV0003-003
There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids.
Z-0167-2009 · View FDA record ↗ - Alpha Omega Services IncTerminatedOct 22, 2008
Alpha-Omega Services, Inc. Product No: SPECIAL-NFV
There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids.
Z-0168-2009 · View FDA record ↗ - Alpha Omega Services IncTerminatedOct 22, 2008
Alpha-Omega Services, Inc. Product No:NFW0001-009
There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids.
Z-0169-2009 · View FDA record ↗ - Alpha Omega Services IncTerminatedOct 22, 2008
Alpha-Omega Services, Inc. Product No:NFW0001-010
There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids.
Z-0170-2009 · View FDA record ↗ - Theragenics CorporationTerminatedUnknown
Theragenics Applicator Needle (18g x 20cm)
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
Z-0643-2019 · View FDA record ↗
Registered firms
57 firms currently registered for this product code
Bard Brachytherapy, Inc
CAROL STREAM, IL, US
Mick Radio-nuclear Instruments, Inc.
MOUNT VERNON, NY, US
C.r. Bard, Inc.
MADISON, GA, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
C.r. Bard, Inc.
COVINGTON, GA, US
Sirtex Germany Manufacturing Gmbh
Frankfurt am Main Hesse, DE
Mtt Gmbh
Lueneburg Lower Saxony, DE
Theragenics Corp.
BUFORD, GA, US
Civco Medical Instruments Co., Inc.
Coralville, IA, US
Isomedix Operations Inc.
GRAND PRAIRIE, TX, US
Radiation Products Design, Inc.
ALBERTVILLE, MN, US
Best Medical International, Inc.
SPRINGFIELD, VA, US
Needle Specialty Products
Boyle, MS, US
Bard Peripheral Vascular, Inc.
TEMPE, AZ, US
Cea Medical Manufacturing, Inc.
Colorado Springs, CO, US
Isoaid, L.l.c.
PORT RICHEY, FL, US
Medxl
ARDMORE, OK, US
Medline Industries, Lp (northpoint Services)
Waukegan, IL, US
Bard Reynosa S.a. De C.v.
REYNOSA Tamaulipas, MX
Tecma Operaciones S. De R.l. De C.v.
Juarez Chihuahua, MX
510(k) clearances
36 clearances for this product code
- Imagyn Medical Technologies, Inc.Dec 3, 2001
K010166 · IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
- Pgk, Inc.Sep 28, 1998
K980997 · PGK DEVICE (MODIFIED)
- Avid N.I.T., Inc.Feb 17, 1998
K972554 · REGANES RADIONUCLIDE SEED MAGAZINE
- Avid N.I.T., Inc.Jan 27, 1998
K973037 · N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000
- Worldwide Medical Technologies, LLCJan 23, 1998
K974118 · WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET
- Nw Radiation Therapy ProductsJan 2, 1998
K973786 · NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE
- Avid N.I.T., Inc.Dec 23, 1997
K973638 · N.I.T., INC. NEEDLE GUIDING TEMPLATE
- Promex, Inc.Nov 21, 1997
K973184 · PROSTATE SEEDING NEEDLE