Medtronic SynchroMed Flex Infusion Programmer Software Application
Medtronic SynchroMed Flex Infusion Mode A810 Clinician Programmer Software may display infusion steps out of order, preventing medication from being delivered at the intended time. Affected devices are clinician programmer tablets worldwide.
What this means for you
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 an FDA Class II device recall with a risk-of-harm issue (failure to deliver medication at intended times in an implanted infusion pump). The source text explicitly states no illnesses or injuries have been reported, but the hazard is not theoretical—medication delivery failure poses a significant risk to patients dependent on the pump. This falls under the High severity criterion.
Plain-English summary
Medtronic Neuromodulation is recalling the SynchroMed Flex Infusion Mode A810 Clinician Programmer Software Application loaded on clinician programmer tablets (models CT900A, CT900B, CT900C, CT900D, CT900E, and CT900F). Approximately 10,165 units were distributed worldwide.
The software issue occurs when programming the SynchroMed infusion pump in Flex Infusion Mode. Infusion steps should automatically be arranged in consecutive order from earliest to latest. However, in rare cases, the steps may be displayed out of order. When this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
Patients and healthcare providers should contact Medtronic Neuromodulation for guidance on their affected device. Specific serial numbers for affected units by model are available through Medtronic.
The recalled product
- Product
- Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- medication-delivery-failure
- software-malfunction
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)
- Software application (app) version 1.x and 2.x
- loaded on the following units: 1. Model Number CT900A
- GTIN 00643169890923
- Serial Numbers: NPL0004445
- 2. Model Number CT900B
- GTIN 00643169890947
- Serial Numbers: NPL1000042
- NPL1000045
- NPL1000046
- NPL1000048
- NPL1000050
- NPL1000051
- NPL1000053
- NPL1000054
- NPL1000059
- NPL1000060
- NPL1000062
- NPL1000065
- NPL1000069
- NPL1000070
Distribution
Distribution scope not specified by the agency.