Invuity PhotonBlade Recalled for Potential Unintended Energy Discharge
Invuity, Inc. is recalling 1,328 units of the INVUITY PhotonBlade device due to reports of unintended energy discharge that could cause tissue damage.
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 risk-of-harm product (potential tissue damage) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Invuity, Inc. is recalling 1,328 units of the INVUITY(R) PhotonBlade(TM), REF PB1, a medical device distributed nationwide. The recall covers all lot numbers.
The recall was initiated after the company received a small number of customer observations regarding possible unintended energy discharge. This issue has the potential to cause tissue damage to patients.
Healthcare providers and consumers should stop using the affected devices immediately. Invuity, Inc. is the recalling firm responsible for managing this safety action.
The recalled product
- Product
- INVUITY(R) PhotonBlade(TM), REF PB1
- Manufacturer
- Invuity, Inc.
- Affected units
- 1,328
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)
- All Lot Numbers
Distribution
Distributed nationwide across the United States.
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