Manufacturer
16 recalls in our database name Greatbatch Medical as the manufacturing or recalling firm.
Of the 16 recalls from Greatbatch Medical we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (6%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Greatbatch Medical is recalling 5,000 ViaPeel PTFE Peelable Introducer 5FR devices because handles may detach during use.
Greatbatch Medical is recalling 11,360 MobiCath Bi-Directional Guiding Sheaths because one side of the pouch may not be sealed.
Greatbatch Medical is recalling specific Linear Straight Broach Handles because they may break at the welds or lose the locating pin during use.
Greatbatch Medical is recalling 1,441 T5766 Offset Reamer Handles because the drive chain U-joints may seize during hip surgery, rendering the device non-functional.
Greatbatch Medical is recalling Standard Offset Cup Impactors with POM-C handle grips because they failed sterility testing when sterilized according to the Instructions for Use.
Greatbatch Medical is recalling Stiffer Coaxial Micro-Introducers because a rotating luer detached from the dilator hub during use.
Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not achieve the required sterility assurance level when steam sterilized.
Greatbatch Medical is recalling torque limiting handles because laboratory testing showed they do not meet required sterility levels after steam sterilization.
Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not meet required sterility levels after steam sterilization.
Greatbatch Medical is recalling Coaxial Micro-Introducer Kits because documentation does not support the claimed five-year shelf life.
Greatbatch Medical is recalling Standard Offset Cup Impactors because internal testing showed the specified sterilization cycles may not achieve the required sterility assurance level.
Cordis and Greatbatch Medical are recalling one lot of RadialSource Spring Wire Transradial Access Kits because some units have an undersized vessel dilator tip that cannot slide over the guidewire.
Greatbatch Medical is voluntarily recalling 913 Small Angled Driver 45 units worldwide due to reports of noisy or rough operation.
Greatbatch Medical is recalling MobiCath Bi-Directional Guiding Sheaths because visual inspections found loose or frayed liner material inside the device.
Greatbatch Medical is recalling MobiCath Bi-Directional Guiding Sheaths due to a potential interaction with therapeutic catheters that may cause them to self-advance.
Greatbatch Medical is recalling 787 units of Boston Scientific Z Flex 270 Steerable Sheaths because damaged internal liners could pose an embolic risk to patients.