Rashkind Balloon Catheter Recessed & Double Lumen (2020-09-09)
- Starting date:
- September 9, 2020
- Posting date:
- September 22, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-73963
Last updated: 2020-09-23
Affected Products
- Rashkind Balloon Catheter Double Lumen
- Rashkind Recessed Balloon Catheter
Reason
Potential for material rupture/balloon failure during procedure. Material rupture / balloon failure during procedure can result in material embolization, balloon leak, balloon burst, inversion or stretching resulting in balloon failure, or surgical intervention.
Affected products
-
Rashkind Balloon Catheter Double Lumen
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 7160
- 7161
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
B. Rashkind Recessed Balloon Catheter
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
8764
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES