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All product recalls associated with Oscor Inc..
Total Recalls
7
Past Year
0
Class I (Serious)
0
Most Recent
Dec 2021
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Potential for open seal on sterile product
Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may become lodged in coronary arteries, which resulting in serious patient outcome and require emergency coronary bypass surgery and medical intervention to remove the retained device fragments.
Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F.
The O-rings are over tolerance making it hard to connect the leads to the pacemaker.
Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton
Sheath size is larger than dilator size causing insertion difficulties.