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All lots/serial numbers for the following devices are affected by this recall.The Vesco Q Pump Sets will continue to be sold along with supplemental instructions for those patients without feed rate sensitivity to continue feeding in effort to prioritize continuity of care. NameModel (REF)Primary UDI-DIVesco Q™ Enteral Feeding PumpVED-70100850002550498Vesco Q™ 500mL Bag Feed Set (PVC)VED-05000850002550450Vesco Q™ 1000mL Bag Feed Set (LL)VED-05100850002550467Vesco Q™ 40mm Screw Cap Feed SetVED-05200850002550474Vesco Q™ ENPlus Spike Feed SetVED-05300850002550481Vesco Q™ 1000mL Bag Feed Set (PVC)VED-05400810096150639Vesco Q™ 100mL Small Bore Bag Feed SetVED-05900810096151377
Over- or under-delivery of enteral nutrition through the Q Pump and associated feed sets could cause temporary or medically reversible adverse health consequences, with a remote probability of serious adverse health consequences. Supplemental instructions are available to mitigate the risk of over or under-delivery. As of September 30, 2026, Vesco Medical has received 3 reports of adverse health consequences related to this issue. No deaths have been reported. See notification letter for additional details.
All lots/serial numbers for the following devices are affected by this recall.NameModel (REF)Primary UDI-DIVesco Q™ Enteral Feeding PumpVED-70100850002550498Vesco Q™ 500mL Bag Feed Set (PVC)VED-05000850002550450Vesco Q™ 1000mL Bag Feed Set (LL)VED-05100850002550467Vesco Q™ 40mm Screw Cap Feed SetVED-05200850002550474Vesco Q™ ENPlus Spike Feed SetVED-05300850002550481Vesco Q™ 1000mL Bag Feed Set (PVC)VED-05400810096150639Vesco Q™ 100mL Small Bore Bag Feed SetVED-05900810096151377
At this time, you or your consignee can continue to use the Q Pump only for patients without feed rate sensitivity under supplemental instructions. Patients with feed rate sensitivity are to stop using the Q Pump and seek an alternate pump from your supplier. Consult your prescribing physician with any questions.
The Q Pump and Q Feeding Sets may be used for patients without feed rate sensitivity under supplemental instructions if the patient can be appropriately monitored. Patients with feed rate sensitivity are advised to stop using the Vesco Q™ Enteral Feeding Pump and seek a suitable alternate pump immediately. Patients are to consult their prescribing physician to if they are unsure if they are feed rate sensitive or if they have any other clinical questions.
Vesco can offer gravity feeding sets as a replacement if an alternative pump and set are not readily available. You or your consignee can continue to use the Q Pump for patients without feed rate sensitivity under supplemental instructions if the patient can be appropriately monitored. The pumps do not need to be returned at this time.
No.At this time, you or your consignee can continue to use the Q Pump for patients without feed rate sensitivity under supplemental instructions if the patient can be appropriately monitored.Patients with feed rate sensitivity are to stop using the Vesco Q™ Enteral Feeding Pump and seek a suitable replacement. Consult your prescribing physician with any questions.Vesco can offer gravity feeding sets as a replacement if an alternative pump and set are not readily available. End Users. Work with your home care provider to return the Q Pump and/or secure an alternative pump.
For patients who are not sensitive to feed rate, continued use may be appropriate if the treating physician determines that precise delivery rate is not clinically necessary and if the patient can be appropriately monitored. Limiting the volume in the feeding container to the amount intended for a single feeding period mitigates the risk of over-delivery. Confirming the feeding container is empty after feeding mitigates the risk of under-delivery. If the Q Pump continues to be used temporarily, follow these supplemental instructions:Pour only the prescribed volume for that feeding into the container. Do not add extra formula for later feedings.For priming purposes, add 15 ml to the prescribed feeding volume when filling the container to account for the priming volume required by the feed set.Only set feed rate, not total dose. When the container empties, the pump will trigger an Air in Line alarm; this is expected. When this alarm sounds, immediately disconnect the feed set from the patient before acknowledging the alarm on the pump.Confirm the pump has stopped once the container is empty.Use commercially prepared formulaDo not use the Bolus Feed Program during this recall period. The Bolus Feed mode delivers at a fixed rate of 600 ml/hr, which increases the potential impact for delivery inaccuracy.Ensure the bottom of the feeding container is positioned at least 6 inches (15 cm) above the top of the pump at all times during feeding. Deviations from this position may further affect delivery accuracy.Monitor the patient and feeding container throughout each feeding session, particularly for patients who cannot communicate discomfort (including pediatric subpopulations particularly infants and young children, patients with altered mental status, dementia, etc.). Report signs of feeding intolerance, such as vomiting, abdominal distension, or diarrhea, to the prescribing physician promptly.Note for Pediatric Patients (including infants >1 month of age): Infants and young children are at heightened risk from delivery inaccuracy. Unless the treating physician has specifically determined that continued use is safe for the individual pediatric patient, cessation of use and transition to an alternate pump is strongly recommended for this population. Caregivers of pediatric patients should contact the prescribing clinician before continuing use under the supplemental instructions.
To maintain continuity of care where appropriate, Vesco Medical continues to supply Q Feeding sets to support the Q Pump. Link to Supplemental InstructionsFor patients sensitive to feed rate, including but not limited to, vulnerable populations such as pediatric subpopulations, patients receiving insulin dosed to their prescribed feeding rate, patients with metabolic disorders requiring continuous carbohydrate delivery, fluid-restricted patients, patients being fed jejunally, and any patient for whom the prescribing physician determines that precise delivery rate is clinically necessary, stop using the Q Pump and seek an alternate pump from your supplier.For patients not sensitive to feed rate, follow the supplemental instructions provided to continue using the Q Pump.Consult your prescribing physician with any questions.Supplemental instructions for patients who are not sensitive to feed rate: Pour only the prescribed volume for that feeding into the container. Do not add extra formula for later feedings.For priming purposes, add 15 ml to the prescribed feeding volume when filling the container to account for the priming volume required by the feed set.Only set feed rate, not total dose. When the container empties, the pump will trigger an Air in Line alarm; this is expected. When this alarm sounds, immediately disconnect the feed set from the patient before acknowledging the alarm on the pump.Confirm the pump has stopped once the container is empty.Use commercially prepared formulaDo not use the Bolus Feed Program during this recall period. The Bolus Feed mode delivers at a fixed rate of 600 ml/hr, which increases the potential impact for delivery inaccuracy.Ensure the bottom of the feeding container is positioned at least 6 inches (15 cm) above the top of the pump at all times during feeding. Deviations from this position may further affect delivery accuracy.Monitor the patient and feeding container throughout each feeding session, particularly for patients who cannot communicate discomfort (including pediatric subpopulations particularly infants and young children, patients with altered mental status, dementia, etc.). Report signs of feeding intolerance, such as vomiting, abdominal distension, or diarrhea, to the prescribing physician promptly.Note for Pediatric Patients (including infants >1 month of age): Infants and young children are at heightened risk from delivery inaccuracy. Unless the treating physician has specifically determined that continued use is safe for the individual pediatric patient, cessation of use and transition to an alternate pump is strongly recommended for this population. Caregivers of pediatric patients should contact the prescribing clinician before continuing use under the supplemental instructions.
If you or your consignee has a pump directly related to a complaint, reach out to Vesco Medical Customer/Quality Support is available at (833) 377-8399 between 8AM and 6PM EST or email us at info@vescomedical.com for a return authorization. Free shipping will be provided for those pumps that require a return authorization back to Vesco.End Users: Work with your home care provider to return the Q Pump and/or secure an alternative pump.
Once posted, this recall will be listed in the FDA Medical Device Recalls database at www.fda.gov/medical-devices/medical-device-recalls. The recall number has not yet been assigned. You can also find the latest updates, supplemental instructions, supplemental instructions video, field action announcements/updates at www.vescomedical.com/q-pump-field-action.
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