ARES CATHETER (2020-12-08)
- Starting date:
- December 8, 2020
- Posting date:
- December 24, 2020
- 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-74649
Last updated: 2020-12-24
Affected Products
A. ARES VENTRICULAR CATHETER WITH RIGHT ANGLE CLIP AND STYLE
B. ARES PERITONEAL CATHETER
C. ARES KIT VENTRICULAR CATHETER WITH RIGHT ANGLE CLIP AND STYLET AND PERITONEAL CATHETER
Reason
During routine post-sterilization inspection, Medtronic identified that there is a potential for a defect on the seal of the outer pouch of specific lots of the Ares catheters. Internal testing has shown that approximately 3 percent of pouches are potentially impacted by this condition. This defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention. To date, Medtronic has not received any reports of patient harm or any complaints related to this issue.
Affected products
A. ARES VENTRICULAR CATHETER WITH RIGHT ANGLE CLIP AND STYLE
Lot or serial number
10265137
10265138
10278409
10297691
10297693
10297696
10353501
Model or catalog number
91101
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
B. ARES PERITONEAL CATHETER
Lot or serial number
10273893
10278418
10312362
10316961
Model or catalog number
93092
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
C. ARES KIT VENTRICULAR CATHETER WITH RIGHT ANGLE CLIP AND STYLET AND PERITONEAL CATHETER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
95001
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES