- The FDA has announced that Medtronic Plc MDT has expanded the Class I recall of its MiniMed 600 series insulin pumps.
- Medtronic is offering to replace all MiniMed 600 series insulin pumps that have a clear retainer ring. The retainer ring helps to lock the insulin cartridge into place in the pump's reservoir compartment.
- If the cartridge is not locked firmly into place, under or over insulin delivery may occur.
- In a separate update, FDA said Medtronic expanded an August 2018 recall of remote controllers used with the MiniMed 508 and Paradigm family of insulin pumps due to cybersecurity risks.
- FDA said it was unaware of any reports of harm to patients related to the cybersecurity problem.
- The FDA said that Medtronic is recalling 31,310 devices because an unauthorized person could record the wireless communication between the remote and insulin pump.
- Patients who have not programmed a remote controller ID into the pump or selected the related bolus option are not affected.
- Related: Medtronic Pulls Plug On Heart Implant Device Amid Growing Concerns Over Patient Safety.
- Price Action: MDT stock is down 0.20% at $125.55 during the market session on the last check Wednesday.
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