Medela Invia Motion Negative Pressure Wound Therapy System Recalled for Battery Error
Medela Inc is recalling 778 units of the Invia Motion Negative Pressure Wound Therapy System because the device may display a battery missing error.
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 is classified as FDA Class II. The hazard involves a functional error (battery missing) in a medical device used for wound therapy, which poses a risk of harm if the device fails to function as intended, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medela Inc is recalling 778 units of the Invia Motion Negative Pressure Wound Therapy System. The affected products are labeled as Endure Negative Pressure Wound Therapy (Models 087.4010 and 087.4020), 15 Days Negative Pressure Wound Therapy (Models 087.4012 and 087.4022), and 60 Days Negative Pressure Wound Therapy (Models 087.4014 and 087.4024). The recall is classified as Class II by the FDA.
The recall was initiated because the device may display a battery missing error. The Invia Motion system is indicated for patients who would benefit from a suction device to promote wound healing by preparing the wound bed, reducing edema, and removing exudate and infectious material.
The affected units were distributed domestically in the United States to AR, CA, FL, GA, IL, IN, LA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, and TX. They were also distributed internationally to Spain, Italy, Denmark, Sweden, Switzerland, and the Netherlands. Specific serial numbers are listed in the official recall documentation.
The recalled product
- Product
- Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure…
- Manufacturer
- Medela Inc
- Category
- Medical Device — Wound Care
- Affected units
- 778
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 (20)
- a. Endure Negative Pressure Wound Therapy (Expected life 3 years)
- b. 15 Days Negative Pressure Wound Therapy (Expected life 15 days)
- c. 60 Days Negative Pressure Wound Therapy (Expected life 60 days)
- d. Endure Negative Pressure Wound Therapy (Expected life 3 years)
- e. 15 Days Negative Pressure Wound Therapy (Expected life 15 days)
- 1670490
- 1670492
- 1670496 1670512
- 1675368 1675419
- 1675421 1675431
- 1675433 1675443
- 1675449
- 1676316 1676365
- 1676662 1676709
- 1676711
- 1676713
- 1676715
- 1676718 - 1676753
- 1676755 1676756
- 1676758 1676759
Distribution
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