The Implant Files -
International Medical Devices Database
- About this investigation
- International Medical Devices Database
- Tell us your story
- Resources for patients
- Reporting partners
- Video introduction
Articles - Patients harmed by medical devices
- Europe, a device gateway to the world
- History of the industry
- The Medtronic way
- Ruptured trust and breast implants
- Heart device raises risk questions
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Adresse du fabricant
Medtronic Navigation, Inc., 826 Coal Creek Cir, Louisville CO 80027-9710
- Société-mère du fabricant (2017)
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Commentaire du fabricant
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
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Source
USFDA
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64 Events
- Rappel de Device Recall Medtronic Passive Planar Blunt Probe
- Rappel de Device Recall Medtronic Navigated Cannulated Taps
- Rappel de Device Recall Medtronic Passive Biopsy Needle Kit
- Rappel de Device Recall Medtronic Passive Biopsy Needle Kit
- Rappel de Device Recall BioTex Reusable Adapter Kit
- Rappel de Device Recall Visualase Cooled Laser Applicator System (VCLAS)
- Rappel de Device Recall StealthStation System
- Rappel de Device Recall StealthStation System
- Rappel de Device Recall StealthStation System
- Rappel de Device Recall StealthStation System
- Rappel de Device Recall StealthStation System
- Rappel de Device Recall StealthStation System
- Rappel de Device Recall StealthStation System
- Rappel de Device Recall Touch N Go pointer
- Rappel de Device Recall StealthStation System Update
- Rappel de Device Recall Visualase(TM) Cooled Laser Applicator System (VCLAS) 15MM TIP
- Rappel de Device Recall Medtronic Straight Suction
- Rappel de Device Recall Medtronic Curved Suction 70
- Rappel de Device Recall Medtronic Curved Suction 90
- Rappel de Device Recall Medtronic Suction Small AxiEM ENT
- Rappel de Device Recall Medtronic Instrument Set EM ENT
- Rappel de Device Recall Medtronic Instrument Kit Fusion ENT
- Rappel de Device Recall Medtronic Set Supplemental INS AxiEM ENT
- Rappel de Device Recall Medtronic ENT Prgm Add Fusion Nav AxiEM
- Rappel de Device Recall Spinous Process Clamp
- Rappel de Device Recall Spinous Process Clamp
- Rappel de Device Recall Spinous Process Clamp
- Rappel de Device Recall Spinous Process Clamp
- Rappel de Device Recall Spinous Process Clamp
- Rappel de Device Recall Cooled Laser Ablation System
- Rappel de PATIENT TRACKER 9733534XOM ENT 1PK
- Rappel de PIN, 9733235, 100MM, STERILE, PERC REF
- Rappel de PIN, 9733236, 150MM, STERILE, PERC REF
- Rappel de SHUNT KIT 9733605 NONINVASIVE
- Rappel de STRL SPHERE
- Rappel de STRL SPHERE
- Rappel de TUBE STERILE OARM 20PK
- Rappel de ADD FUSION NAV AxiEM
- Rappel de INST 9731132 KIT CR REF FRAME DRIVER 5PK
- Rappel de SPHERES 8801071 1/TRAY 12PK
- Rappel de SPHERES 8801075 5/TRAY 12PK
- Rappel de TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
- Rappel de TRAJ GUIDE KIT, 9733066, BIOPSY, INT
- Rappel de TUMOR RES. PACK 9733553 AxiEM S.M.
- Rappel de TUMOR RESECTION KIT 9733607 NONINVASIVE
- Rappel de TUMOR RESECTION KIT 9733608 SKULL MOUNT
- Rappel de UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
- Rappel de INSTRUMENT TRACKER 9733533XOM ENT 1PK
- Rappel de KIT, 9731427, THORACIC TACTILE PROBES
- Rappel de MOUSE 9732721 STERILE OARM 10PK
- Rappel de PACK 9731975 TUMOR RESECTION AXIEM CR
- Rappel de PAK 9733497 NAV NIMSPINE PEDICLE ACC KT
- Rappel de BAG 9732315 MOUSE STERILE 15 PK
- Rappel de BIOPSY NEEDLE KIT
- Rappel de BIT 2.9mm DRILL
- Rappel de Device Recall Left Long Tactile Probe
- Rappel de Device Recall Right Long Tactile Probe
- Rappel de Device Recall Medtronic Navigation
- Rappel de Device Recall STEALTHSTATION TREATMENT GUIDANCE PLATFORM
- Rappel de Device Recall DICOM Query/Retrieve, version 1.1.4
- Rappel de Medtronic Navigated Solera Screwdrivers
- Rappel de Medtronic Navigated Solera Screwdrivers
- Rappel de Visualase Visualization Stylets
- Rappel de Visualase Body Accessory Kit
64 dispositifs dans la base de données
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Modèle / numéro de série
lot number 150223
- Classification du dispositif
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Classe de dispositif
2
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Dispositif implanté ?
No
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Distribution
US Distribution to the states of : CA, MO, LA and PA., and Internationally to Ireland.
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Description du dispositif
Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked, reusable instrument used in navigated surgery and is included with Medtronic cranial instrument kits. It is designed for use in patient registration and palpating brain tissue during surgical procedures.
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Modèle / numéro de série
Correction includes all lots of products distributed between January 2007 and March 2015. P/N: 9734240,Nav 6.5mm Tap (Cannulated),9734239, Nav 5.5mm Tap (Cannulated), 9734238,Nav 4.5mm Tap (Cannulated), 9734302,6.5mm Tap (Cannulated),9734300,5.5mm Tap (Cannulated),9734298,4.5mm Tap (Cannulated),9734303,7.5mm Tap (Cannulated),9734301,6.0mm Tap (Cannulated),9734299,5.0mm Tap (Cannulated),9734304,8.5mm Tap (Cannulated),9730944,4.5 mm Cannulated Tap,9730945,5.5 mm Cannulated Tap,9730946,6.5 mm Cannulated Tap,9733182,4.0 mm Cannulated Tap, 1.86P,9733183,4.5 mm Cannulated Tap,9733184,4 mm Cannulated Tap, 1.5P, UCSS,960-347,7.5 Old Round APT (Cannulated Tap-Tip only),960-345,6.5 Old Round APT (Cannulated Tap-Tip only),960-344,5.5 Old Round APT (Cannulated Tap-Tip only) The above referenced cannulated taps are included in the kits and,9731921,KIT 9731921 INSTRUMENT SPINE BASIC,9735101,INST KIT 9735101 TAP ASM 4.5 G5, 9735102,INST KIT 9735102 TAP ASM 5.5 G5,9735103,INST KIT 9735103 TAP ASM 6.5 G5,9735107,INST KIT 9735107 TAP ASM 5.0 G5,9735108,INST KIT 9735108 TAP ASM 6.0 G5,9735109,INST KIT 9735109 TAP ASM 7.5 G5,9735149,INST KIT 9735149 CANNULATED 6.5MM TAP,9735150,INST KIT 9735150 CANNULATED 5.5MM TAP,9735151,INST KIT 9735151 CANNULATED 4.5MM TAP,9735168,INST KIT 9735168 4MM TAP 1.86P,9735169,INST KIT 9735169 4.5MM CANN TAP,9735170,INST KIT 9735170 4MM TAP 1.5P,9734490,INST SET 9734490 LEGACY,9734491,INST SET 9734491 SOLERA STD,9734492,INST SET 9734492 SOLERA DEF UPGRADE,9735469,TAPS 9735469 CD HORIZON SOLERA,9734631,TD SET 9734631 LEGACY STD TAPS/DRIVERS,9734632,TD SET 9734632 SOLERA STD TAPS/DRIVERS,9733370,VERTEX MAX SET, 9733370, NAVIGATED,9734838,KIT 9734838 SOLERA 8.5 CANNULATED TAP,
- Classification du dispositif
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Classe de dispositif
2
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Dispositif implanté ?
No
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Distribution
Worldwide Distribution.
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Description du dispositif
Medtronic Navigated Cannulated Taps || Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. || Designed for use in spine surgery to assist in the tapping procedure and the placement of screws during the surgery.
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Modèle / numéro de série
LOT No: 066503515, 066504315, 066506515
- Classification du dispositif
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Classe de dispositif
2
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Dispositif implanté ?
No
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Distribution
Worldwide Distribution - US (nationwide) and Canada.
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Description du dispositif
Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. || The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
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Modèle / numéro de série
LOT No: 0007525461. 0007599312
- Classification du dispositif
-
Classe de dispositif
2
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Dispositif implanté ?
No
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Distribution
Worldwide Distribution - US (nationwide) and Canada.
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Description du dispositif
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. || The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
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Modèle / numéro de série
The adapter kits are not identified with any lot/code numbers. The BioTex Adapter kits were manufactured between 2008 and 2010.
- Classification du dispositif
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Classe de dispositif
2
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Dispositif implanté ?
No
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Distribution
US Distribution to states of: FL, NJ, AZ, and NC.
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Description du dispositif
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization || The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by the physician via stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation Image Guided Workstation System.
15 fabricants avec un nom similaire
En savoir plus sur les données ici
Medtronic Navigation Inc. || Cfi Medical Solutions || Medtronic Navigation, Inc. || Northen Digit...
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Source
NIDFSINVIMA
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Adresse du fabricant
Medtronic Navigation, Inc., 300 Foster St, Littleton MA 01460-2017
- Société-mère du fabricant (2017)
-
Commentaire du fabricant
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
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Source
USFDA
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Adresse du fabricant
Medtronic Navigation, Inc.-Littleton, 300 Foster Street, Littleton MA 01460-2017
- Société-mère du fabricant (2017)
-
Commentaire du fabricant
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
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Source
USFDA
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Adresse du fabricant
Medtronic Navigation, Inc.-Littleton, 300 Foster St, Littleton MA 01460-2017
- Société-mère du fabricant (2017)
-
Commentaire du fabricant
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
-
Source
USFDA
- Société-mère du fabricant (2017)
-
Commentaire du fabricant
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
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Source
AEMPSVFOI