Overview of recall records associated with Medtronic Perfusion Systems, including dates, categories and classifications where available.
Classification mix: Class II: 72, Class I: 12.
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip…
Potential for unsealed sterile packing.
Potential for unsealed sterile packing.
Potential for unsealed sterile packing.
Potential for unsealed sterile packing.
Potential for unsealed sterile packing.
Potential for unsealed sterile packing.
Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure…
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure…
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure…
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure…
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure…
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure…
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Potential for a wire protrusion through the left heart vent catheter tip
Potential for a wire protrusion through the left heart vent catheter tip
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
This page summarizes recall records in which the official source identifies Medtronic Perfusion Systems as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
