3M V.A.C. VIA Negative Pressure Wound Therapy System Recalled for Leak Alarm Malfunctions
KCI USA is recalling approximately 2,169 units of the 3M V.A.C. VIA negative pressure wound therapy system due to increased complaints about leak alarm malfunctions affecting certain units.
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: This is a Class II medical device used for serious wound treatment. While no injuries have been reported, malfunction of leak detection alarms represents a risk of harm by preventing users from detecting device failures during critical treatment.
Plain-English summary
KCI USA, Inc. is recalling approximately 2,169 units of the 3M V.A.C. VIA Negative Pressure Wound Therapy System. The recall was initiated due to an increase in complaints related to leak detection alarms on certain devices.
The affected devices include specific product variants: the V.A.C. VIA 7 Day Kit (REF: VIAKIT077D01/US), the V.A.C. VIA Starter Kit (REF: VIAKIT07S05/AU), and the V.A.C. VIA 7 Day Kit Single Shipper (REF: VIAKIT077D01/GB), with specific lot numbers identified for each variant.
These devices have been distributed throughout the United States and to multiple countries worldwide. Patients and healthcare providers using these devices should check the FDA recall notice for their specific product's lot number and contact KCI USA, Inc. for further guidance.
The recalled product
- Product
- 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper
- Manufacturer
- KCI USA, INC.
- Hazard
- Affected units
- 2,169
Distribution
Part of a larger recall action
This product is one of 2 recalled by KCI USA, 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.
See all 2 products in this recall →Related recalls
Same manufacturer · KCI USA, INC.
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