DiamondTOUCH Digital Inflation Device Sterile Barrier Defect Recall
Merit Medical Systems is recalling the DiamondTOUCH Digital Inflation Device due to a small hole in the sterile barrier. The defect may expose patients to pathogens or pyrogens, potentially causing infection.
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: FDA Class II medical device recall with no reported illnesses or injuries. The sterile barrier defect presents a significant risk of infection from pathogen/pyrogen exposure, meeting the criteria for High severity as a risk-of-harm product without yet-reported injury.
Plain-English summary
Merit Medical Systems, Inc. is recalling the DiamondTOUCH Digital Inflation Device (REF: IN9135/A, IN9152/A). The devices may have a small hole in the sterile barrier.
If the sterile barrier is compromised, patients using the device may be exposed to pathogens or pyrogens, which could lead to infection. A total of 290 affected units have been distributed worldwide, including throughout the United States and internationally to France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, and Japan.
Healthcare facilities and practitioners should contact Merit Medical Systems for further guidance regarding affected devices.
The recalled product
- Product
- DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 290
Distribution
Part of a larger recall action
This product is one of 10 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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