Terumo Recalls Hercules 360 Universal Stabilizing Arms Due to Pin Separation
Terumo CVS is recalling Hercules 360 Universal Stabilizing Arms because pins may come loose and fall into the surgical site.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where components may fall into a surgical site, representing a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules 360 Universal Stabilizing Arms. The recall involves 260 distributed devices with serial numbers ranging from 70194 through 70504. The devices are reusable stainless steel stabilizing arms with a top mount and 360-degree rotation.
The recall is being issued because the two pins that hold the sleeve attached to the distal end of the device may come loose. This can cause the pins and sleeve to separate from the device. While the arm can still function without these components, there is a potential for the loose parts to fall into the surgical site.
Terumo CVS has identified 16 domestic consignees and 30 international consignees. The source text does not specify specific actions for consumers or patients, as the devices are distributed to medical facilities.
The recalled product
- Product
- Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 260
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number Range 70194 through 70504
Distribution
Distribution scope not specified by the agency.
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