Health product recall

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

  1. Rashkind Balloon Catheter Double Lumen
  2. 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

  1. 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