FDA issues emergency alert after reports of 5 serious injuries connected to exploding cryoprobes
The U.S. Food and Drug Administration has released an early alert pertaining to patient safety, after the agency said it became aware of an issue with flexible cryoprobes—used to deliver extreme cold to a site on the body for a variety of medical purposes, including removing tissue tumors—manufactured by Erbe USA.
According to the FDA, the company reported incidents of its cryoprobes “rupturing or bursting during activation,” leading to excessive pressure at sites of foreign bodies, mucus plugs, blood clots, necrotic tissue, or biopsies—essentially anything a provider is trying to remove.
The issue is reported by Erbe to be caused by a manufacturing defect that left an insufficient layer of structural adhesive applied to the devices. When pressure is applied, they can break. However, the issue only impacts certain lots.
All products impacted by this recall are considered dangerous, not only to patients. Anyone near them when they erupt is subjected to a loud sound, in addition to the risk of being burned by ejected cryogenic substances.
The defect could cause tinnitus or hearing loss to both clinicians and patients, the FDA said. The agency is seeking to have all affected cryoprobes removed from where they are used and sold.
To date, there have been five serious injuries reported, all linked to the inadequate adhesive causing a rupture. No one has died.
What is being recalled?
The Erbe Flexible Cryoprobe subject to the recall can be identified in the chart provided by the FDA.
A complete list of all impacted lots can be found by clicking here to access a spreadsheet.
Next Steps
All affected products can be identified based on the information above. They must then be removed and quarantined to ensure they are not used or sold. Facilities that typically use cryoprobes include hospitals, surgery centers, and other patient care clinics.
The FDA said Erbe notified all known customers in February about the manufacturing defect and dangers associated with the device. In the company’s letter, it asked all potential users to:
- Discontinue use of products with the affected lot numbers.
- If any affected products were sold or distributed to other facilities, notify them to ensure they are aware of this emergency recall.
For more information, Erbe can be contacted at 770-955-4400. This number can also be used to request a refund or replacement.
The FDA is still assessing the scope of the problem. It’s asking anyone with more information on adverse events to submit a report by clicking here.
The agency’s full alert can be found by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.