Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing (2020-12-15)
- Starting date:
- December 15, 2020
- Posting date:
- December 30, 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-74671
Last updated:
2020-12-30
Affected Products
- Penumbra JET 7 Reperfusion Catheter
- Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing
Reason
The Catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage, and subsequent patient injury or death.
Affected products
A. Penumbra JET 7 Reperfusion Catheter
Lot or serial number
- All lots.
Model or catalog number
5MAXJET7
Companies
- Manufacturer
-
Penumbra Inc.
1351 Harbor Bay Parkway
Alameda
94502
California
UNITED STATES
B. Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing
Lot or serial number
- All lots.
Model or catalog number
5MAXJET7KIT
Companies
- Manufacturer
-
Penumbra Inc.
1351 Harbor Bay Parkway
Alameda
94502
California
UNITED STATES