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Peripheral and Flextome Cutting Balloons (2013-08-06)
- Starting date:
- August 6, 2013
- Posting date:
- April 14, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38983
Recalled Products
A. Peripheral Cutting Balloon
B. Flextome Cutting Balloon
Reason
May experience significant difficulty or inability to remove the protector cap from the device which may result in damage to the device.
Affected products
A. Peripheral Cutting Balloon
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
M001BPM4015140F0
Companies
- Manufacturer
-
Boston Scientific Corporation
One Boston Scientific Place
Natick
01760
Massachusetts
UNITED STATES
B. Flextome Cutting Balloon
Lot or serial number
15780571
Model or catalog number
H749RB4400150
Companies
- Manufacturer
-
Boston Scientific Corporation
One Boston Scientific Place
Natick
01760
Massachusetts
UNITED STATES