ACUSON AcuNav Volume ICE catheter (2020-06-05)
- Starting date:
- June 5, 2020
- Posting date:
- June 16, 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-73363
Last updated: 2020-06-16
Affected Products
ACUSON AcuNav Volume ICE catheter
Reason
Siemens Healthineers has received reports of left atrial perforations and AV (atrioventricular node) block occurring while the acuson acunav volume ice catheter is enabling structural heart interventional procedures.
Affected products
ACUSON AcuNav Volume ICE catheter
Lot or serial number
- 10855958
Model or catalog number
- 10855958
Companies
- Manufacturer
-
Siemens Medical Solutions USA Inc.
685 East Middlefield Road
Mountain View
94043
California
UNITED STATES