Health product recall

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

  1. Penumbra JET 7 Reperfusion Catheter
  2. 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