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Crédits
Devices
Device Recall Boston Scientific Scimed
Modèle / numéro de série
Lot numbers 5458926, 5459705, 5462880, 5464053, 5523106, 5570556, 5576584, and 5581120
Classification du dispositif
Cardiovascular Devices
Distribution
The recalled products were shipped to hospitals located nationwide in the United States.
Description du dispositif
Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-5020
Manufacturer
Boston Scientific Scimed
1 Event
Rappel de Device Recall Boston Scientific Scimed
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Fabricant
Boston Scientific Scimed
Adresse du fabricant
Boston Scientific Scimed, One Scimed Place, Maple Grove MN 55311-1566
Source
USFDA
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Device Recall Boston Scientific Scimed Express 2 Monorail
Modèle / numéro de série
Lot number 5140999
Classification du dispositif
Cardiovascular Devices
Classe de dispositif
3
Dispositif implanté ?
Yes
Distribution
The product was shipped to 18 hospitals located nationwide in the United States. There are no US Government or foreign accounts.
Description du dispositif
Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250
Manufacturer
Boston Scientific Scimed
Device Recall Boston Scientific Scimed
Modèle / numéro de série
Lot number 5350420
Classification du dispositif
Cardiovascular Devices
Classe de dispositif
3
Dispositif implanté ?
Yes
Distribution
Nationwide in the United States
Description du dispositif
Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number H74917485400
Manufacturer
Boston Scientific Scimed
Device Recall Boston Scientific Scimed
Modèle / numéro de série
Lot number 5357125
Classification du dispositif
Cardiovascular Devices
Classe de dispositif
3
Dispositif implanté ?
Yes
Distribution
Nationwide in the United States
Description du dispositif
Boston Scientific Scimed Radius 3.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500301
Manufacturer
Boston Scientific Scimed
Device Recall Boston Scientific Scimed
Modèle / numéro de série
Lot number 5350197
Classification du dispositif
Cardiovascular Devices
Classe de dispositif
3
Dispositif implanté ?
Yes
Distribution
Nationwide in the United States
Description du dispositif
Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500401
Manufacturer
Boston Scientific Scimed
Device Recall Boston Scientific Scimed
Modèle / numéro de série
Lot numbers 5490976, 5530109, and 5564475
Classification du dispositif
Cardiovascular Devices
Distribution
The recalled products were shipped to hospitals located nationwide in the United States.
Description du dispositif
Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm / 1.5 cm /90 cm (balloon width/balloon length/catheter length), Reference Catalog Number 37915-4015
Manufacturer
Boston Scientific Scimed
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