· Published by Health Canada · Official notice
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| DLP Retrograde Cardioplegia Cannulae | 0231757975 | 94113T |
| DLP Retrograde Cardioplegia Cannulae | 0231667046 | 94113T |
| DLP Retrograde Cardioplegia Cannulae | 0231651336 | 94113T |
On 8-January-2026, Medtronic received a complaint from the U.S. reporting that a seal of a pouch containing the cannula was not fully sealed (chevron side) and opened to the air. The customer reported that they identified seventeen (17) cannulae with open pouches and therefore considered the product unsterile. There was no patient involvement in the complaint.