Medtronic MiniMed, Inc. recalls InPen smart insulin pen

Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.

On 3/4/2025, correction notices were sent to customers and distributors informing them of the following: 1) If you have already inserted your insulin cartridge into your device without difficulty removing the cartridge holder, then you can continue normal use. 2) If you have a device from one of the affected lot numbers and have not yet started using it, or have had difficulties in removing the cartridge holder or inserting the insulin cartridge, please call 1-800-646-4633, option 1, or go to https://info.medtronicdiabetes.com/ICH-replacement-form to request a replacement product. Do not use this device and dispose of it according to local regulations. 3) Complete and return the confirmation form via link: https://info.medtronicdiabetes.com/cartridge-holder Distributors are asked to notify impacted customers. If you have further questions or need assistance, please call the firm's 24-Hour Technical Support line at 1-800-646-4633, option 1.

• FDA enforcement recordOfficial FDA database entry for Z-1650-2025
• FDA 510(k) clearance · K160629The device's official FDA premarket clearance record
• FDA 510(k) clearance · K190487The device's official FDA premarket clearance record
• FDA 510(k) clearance · K192841The device's official FDA premarket clearance record
• FDA 510(k) clearance · K201337The device's official FDA premarket clearance record
• FDA 510(k) clearance · K242775The device's official FDA premarket clearance record
• FDA device classification · FMFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5860The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medtronic MiniMed, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.