Re-Entry Malecot Nephrostomy Catheter (2017-12-13)
- Starting date:
- December 13, 2017
- Posting date:
- January 8, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-65598
Affected Products
Re-Entry Malecot Nephrostomy Catheter
Reason
Certain Malecot Nephrostomy Catheters due to reports of some catheters breaking at the mid-shaft bond during use. The bond is located where the renal end of the Malecot Catheter is bonded to the catheter shaft. Boston Scientific Corporation (BSC) has received seventeen (17) complaints for this issue since December 1, 2013.
Affected products
Re-Entry Malecot Nephrostomy Catheter
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
M0064101010
M0064101050
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES