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Official recall record

DLP Cardiac Vents & Sumps

Health Canada — Medical Devices · 2025-09-24 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2025-09-24
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: Health Canada — Medical Devices · Canada · all filters

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