Medtronic Hemocor Hemoconcentrators Recalled for Low Ultrafiltration Performance
Medtronic Perfusion Systems is recalling Hemocor Hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.
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, and the hazard involves a performance defect in a medical device used for patient management, which fits the criteria for a High severity score where injury has not yet been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling the MEDIVATORS HEMOCOR HPH700, HPH-1400TS, and HPH-1000TS hemoconcentrators. These devices are used by perfusionists to manage a patient's hematocrit and fluid status. The recall is due to the devices demonstrating low ultrafiltration performance that is below product specification.
A total of 1,594 units are affected, including 1,306 in the United States and 288 outside the US. The devices were distributed worldwide, including in specific US states and countries such as Bolivia, Denmark, and Italy. The affected units were distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs.
The recall is classified as Class II by the FDA. Consumers and healthcare facilities should contact Medtronic Perfusion Systems for further instructions on how to handle these devices.
The recalled product
- Product
- MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
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 (1)
- 759625A 759884A 759491A 762355A
Distribution
Part of a larger recall action
This product is one of 2 recalled by Medtronic Perfusion Systems 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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