EZ Glide Cannula, Straight, Curved With Suture Bump & Curved With Suture Flange (2019-10-24)
- Starting date:
- October 24, 2019
- Posting date:
- November 1, 2019
- 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-71465
Last updated: 2019-10-29
Affected Products
A. EZ Glide Cannula, Straight
B. EZ Glide Cannula, Curved With Suture Bump
C. EZ Glide Cannula, Curved With Suture Flange
Reason
Edwards Lifesciences has initiated a recall of the EZ Glide product after receiving three (3) reports that an EZ Glide Cannula separated from its connector, causing a breach of the cardiopulmonary bypass (CPB) circuit and loss of blood. In each case, the report suggests that the separation occurred without any significant force being applied to the joint. Although the occurrence rate is 0.0034%, And all patients had successful surgical outcomes, in the interests of patient safety and transparency, Edwards is notifying customers of the events and requesting return of EZ Glide devices.
Affected products
A. EZ Glide Cannula, Straightj
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- EZS21A
- EZS21TA
- EZS24A
- EZS24TA
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
92614
California
UNITED STATES
B. EZ Glide Cannula, Curved With Suture Bump
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- EZC21A
- EZC21TA
- EZC24A
- EZC24TA
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
92614
California
UNITED STATES
C. EZ Glide Cannula, Curved With Suture Flange
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- EZF21A
- EZF21TA
- EZF24A
- EZF24TA
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
92614
California
UNITED STATES