Medtronic MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter recall — FDA Z-2201-2024
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Complete FDA and NHTSA recall records dated in July 2024.
These records include useful source details for the selected month.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Potential for coils to heat up and harm patients (burn).
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650…
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in…
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.