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Another Class I recall. Patients implanted should be informed- but how?

Another Class I recall. Patients implanted should be informed- but how?


The FDA is alerting physicians about a recall of HeartWare VAD Pump Implant Kit, categorized as a Class I recall, its most serious type. All healthcare providers and physicians should inform their patients. But, like thousands of hospitals, there is almost no way of keeping track of the patients or the inventory inside the core storerooms.

The lack of complete device information in the patient medical records and the manual method of documentation that currently perform in hospitals went from an inconvenience to an immediate threat.

Following 27 complaints of serious injuries and Two deaths have been reported, Medtronic initiated a recall of the HeartWare Ventricular Assist Device (HVAD) Pump Implant Kits.

Inform patients implanted- Mission Impossible?

In the Urgent Medical Device Communication Letter sent by Medtronic, all healthcare providers and physicians should be aware of the affected device and review the attached serial numbers to confirm and Inform patients implanted with one of these identified pumps and to coordinate performing an exchange of controllers in a clinical setting if necessary. This notice must be shared with all those who need to be aware of within the organization.

Although the blessed UDI regulation offers a pathway to make the information accessible, the current data-capture methods are still depending on barcode scanning, and their limited ability to track batch numbers and link the information straight to the patients. As of this writing, there appears to be a much lower number of UDIs in recalls than would be expected based upon the ever-increasing availability of UDI on device labels.


Smart alerts system for recalled or expired items

From this critical need, IDENTI developed the Snap & Go platform. A smart sensor based on image recognition technology and advanced AI and machine learning algorithms. This easy-to-use platform identifies medical implants and consumables, documents their use and tracks product integrity (recall and expiration dates). “Snapping” an item is quick, easy and ensures full item documentation – batch no., manufacture’s catalog no., serial no. and expiry date – a feat that today’s barcode systems do not achieve.

A staff member simply places the consumed item under the camera, and within seconds an image is captured, identified and routed through a global database and an advanced AI & ML algorithm into the hospital’s ERP & EHR systems. Alerts for any recalled or expired items that are in use appear on-screen.

Olivia Walker is IDENTI’s Global Marketing Director and has a wealth of experience in the healthtech sectorHer innovative marketing strategies have successfully driven IDENTI’s growth in multiple worldwide marketsHer strength is the ability to identify what truly resonates within the industry. She is passionate about building relationships and her expertise lies in creating meaningful partnerships with healthcare providers, distributors, and suppliers.

Medical Recall


 Usage capture at point-of-use

Tissue and implant tracking

Medical supplies replenishment

Full control over narcotics and medications


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