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Device Recall Boston Scientific Scimed
Model / Serial
Lot numbers 5486922 and 5625627
Product Classification
Cardiovascular Devices
Distribution
The recalled products were shipped to hospitals located nationwide in the United States.
Product Description
Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-6015
Manufacturer
Boston Scientific Scimed
1 Event
Recall of Device Recall Boston Scientific Scimed
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Manufacturer
Boston Scientific Scimed
Manufacturer Address
Boston Scientific Scimed, One Scimed Place, Maple Grove MN 55311-1566
Source
USFDA
32 devices with a similar name
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Device Recall Boston Scientific Scimed Express 2 Monorail
Model / Serial
Lot number 5140999
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
The product was shipped to 18 hospitals located nationwide in the United States. There are no US Government or foreign accounts.
Product Description
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
Model / Serial
Lot number 5350420
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide in the United States
Product Description
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
Model / Serial
Lot number 5357125
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide in the United States
Product Description
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
Model / Serial
Lot number 5350197
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide in the United States
Product Description
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
Model / Serial
Lot numbers 5490976, 5530109, and 5564475
Product Classification
Cardiovascular Devices
Distribution
The recalled products were shipped to hospitals located nationwide in the United States.
Product Description
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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