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All product recalls associated with Datascope Corporation.
Total Recalls
15
Past Year
0
Class I (Serious)
0
Most Recent
Aug 2022
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.
Certain lots containing undersized dilator.
Certain lots containing undersized dilator.
The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.