DLP Cardiac Vents & Sumps
Brand(s)
Last updated
Summary
Product
DLP Cardiac Vents & Sumps
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| DLP Cardiac Vents & Sumps | More than 10 numbers, contact manufacturer. | 12115 |
| DLP Cardiac Vents & Sumps | More than 10 numbers, contact manufacturer. | 12110 |
| DLP Cardiac Vents & Sumps | More than 10 numbers, contact manufacturer. | 12113 |
Issue
Since March 2024, there has been an increase in complaints reported for the DLP malleable left heart vent catheter for the catheters resisting shape retention when being bent. The catheters are intended to be malleable and retain a bend in the shaft. It was determined that the primary supplier updated their specification to remove annealing process to attain tensile strength listed in ASTM1313-18.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Medtronic Inc.
710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78123
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