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
-
Modèle / numéro de série
Lot Numbers: 0000170203 220956
- Classification du dispositif
-
Classe de dispositif
2
-
Dispositif implanté ?
No
-
Distribution
Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
-
Description du dispositif
8F ZUMA 2 SR 5.0 100CM || CATHETER Z28SR50 Z2 8F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. || Product Code: Z28SR50
- Manufacturer
- 1 Event
Fabricant
-
Adresse du fabricant
Medtronic, Inc., 35 -37A Cherry Hill Dr, Danvers MA 01923-2565
-
Source
USFDA
829 dispositifs médicaux avec un nom similaire
En savoir plus sur les données ici
-
Modèle / numéro de série
Model 8731 Base Lot Numbers: B011311N, B011421N, B011422N, B011500N, B011721N, B011737N, B011738N, B011786N, N0012097, N0012140, N0012141, N0012521, N0012692, N0012814, N0012815, N0012816, N0013149, N0013150, N0013352, N0013353, N0013354, N0013355, N0013707, N0013710, N0013936, N0014007, N0014236, N0014237, N0014330, N0014331, N0014332, N0014722, N0015050. *Model 8731 Catheters and Model 8598 Distal Revision kits have a Base Lot number of eight (8) characters plus a two (2) digit suffix that represents serialization within these recalled lots. This list provides just the Base lot Number (the first eight characters of the product Lot No. found on the product labeling).
- Classification du dispositif
-
Classe de dispositif
3
-
Dispositif implanté ?
Yes
-
Distribution
Worldwide Distribution-USA and Austria, Belgium, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom
-
Description du dispositif
Medtronic Intrathecal Catheter, Model 8731, (part of infusion systems using Medtronic implantable pumps) The catheter is designed for use in the intrathecal space. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.
- Manufacturer
-
Modèle / numéro de série
Model 8598 Base Lot Numbers: B011468N, B011893N, B011894N, N0012129, N0012612, N0012969, N0012970, N0012971, N0014057, N0014058, N0014179, N0014180, N0016472. *Model 8731 Catheters and model 8598 Distal Revision kits have a Base Lot number of eight (8) characters plus a two (2) digit suffix that represents serialization within these recalled lots. This list provides just the Base lot Number (the first eight characters of the product Lot No. found on the product labeling).
- Classification du dispositif
-
Classe de dispositif
3
-
Dispositif implanté ?
Yes
-
Distribution
Worldwide Distribution-USA and Austria, Belgium, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom
-
Description du dispositif
Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598, (provides replacement parts for the distal section of the 8731 Intrathecal Catheter) . Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.
- Manufacturer
-
Modèle / numéro de série
serial numbers in the following ranges: ¿ NFD100006 - NFD100325H ¿ NFD620017S - NFD625737S ¿ NFD200201K - NFD201303K
- Classification du dispositif
-
Classe de dispositif
3
-
Dispositif implanté ?
Yes
-
Distribution
Worldwide, including USA, Puerto Rico, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Israel, Italy, Jordan, Lebanon, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.
-
Description du dispositif
Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428. Rx only. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The dual program model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via DBS extension or DBS leads. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case. The operation of the neurostimulator is supported by a clinician programmer, a therapy controller, and a control magnet.
- Manufacturer
-
Modèle / numéro de série
All Codes.
- Classification du dispositif
-
Classe de dispositif
2
-
Dispositif implanté ?
No
-
Distribution
Worldwide, including USA, Switzerland, France, Belgium, Germany.
-
Description du dispositif
Pioneer Catheter (Crosspoint TransAccess Catheter); || Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403
- Manufacturer
-
Modèle / numéro de série
lot numbers: 0610707, 0614409, 0614410, 0614411, 0614412, 0622204
- Classification du dispositif
-
Classe de dispositif
2
-
Dispositif implanté ?
Yes
-
Distribution
Nationwide and Canada.
-
Description du dispositif
Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices.
- Manufacturer