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MEDTRONIC, INC. · Model 8583 · UDI-DI 00643169887596
LKK
Prescription
0
510(k) clearances
117,224
Adverse events (1,634 deaths)
132
Recalls
19
Facilities
Description
ACCY 8583 CATHETER PASSER 38CM US FWU
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-11 | Boston Scientific Corporation | There is the potential for leakage along the drug pathway from the pump through the end of the catheter. |
| 2026-04-08 | Medtronic Neuromodulation | Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from ear |
| 2025-01-09 | Medtronic Neuromodulation | Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump. |
| 2024-11-21 | Medtronic Neuromodulation | Software issues were identified in application version 2.x. |
| 2024-11-21 | Medtronic Neuromodulation | Software issues were identified in application version 2.x. |
| 2024-11-21 | Medtronic Neuromodulation | Software issues were identified in application version 2.x. |
| 2024-11-21 | Medtronic Neuromodulation | Software issues were identified in application version 2.x. |
| 2024-09-11 | Medtronic Neuromodulation | Potential for error and inability to interrogate pump due to data corruption in the pump memory. |
| 2024-05-10 | Medtronic Neuromodulation | Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda cathet |
| 2023-11-13 | Medtronic Neuromodulation | Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.