Boston Scientific Recalls Five ACUITY Universal Cutters Due to Sterilization Failure
Boston Scientific is retrieving five ACUITY Universal Cutters that did not undergo the required sterile processing procedure.
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 that failed to undergo sterile processing, creating a risk of infection or harm. No injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling five units of the ACUITY Universal Cutter, Model 7060. These devices are intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
The recall is being conducted because the five units did not undergo the applicable sterile processing procedure. The affected units are identified by GTIN 08714729936176 and Lot Number H1937249.
The devices were distributed nationwide in the United States, including in Tulsa, Oklahoma. Healthcare providers and facilities should stop using the affected units and contact Boston Scientific for further instructions.
The recalled product
- Product
- ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 5
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 (2)
- GTIN 08714729936176
- Lot Number H1937249
Distribution
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