Pump, Infusion, Implanted, Programmable

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-06-25CompletedProcess control

  Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device

  There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

• 2026-05-14Open, ClassifiedUnder Investigation by firm

  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 UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump

  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 earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.

• 2025-04-01Open, ClassifiedUnder Investigation by firm

  A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.

  Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.

• 2024-12-27Open, ClassifiedUnder Investigation by firm

  SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B

  Software issues were identified in application version 2.x.

• 2024-12-27Open, ClassifiedUnder Investigation by firm

  SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C

  Software issues were identified in application version 2.x.

• 2024-12-27Open, ClassifiedUnder Investigation by firm

  SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D

  Software issues were identified in application version 2.x.

• 2024-12-27Open, ClassifiedUnder Investigation by firm

  SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E

  Software issues were identified in application version 2.x.

• 2024-10-21Open, ClassifiedDevice Design

  SynchroMed II Infusion Pump. Product Number: 8637-20

  Potential for error and inability to interrogate pump due to data corruption in the pump memory.

• 2024-07-12Open, ClassifiedDevice Design

  Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)

  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 catheter connector which may potentially lead to catheter occlusion.

• 2023-12-22Open, ClassifiedUnder Investigation by firm

  Medtronic SynchroMed II, Model 8637-20, Programmable pump

  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 alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.