1. Medtech Insight
  2. >>Policy & Regulation

US FDA Deems MiniMed Safety Issues Class I Recall

 
• By Elizabeth Orr

Medtronic’s MiniMed 600 series of insulin pumps is the subject of a high-risk class I recall because a component may break, leading to over- or under-dosing of insulin. The company warned patients of the issue last November.

detailed illustration of a compass with Recall text, eps10 vector

A mechanical issue that could lead to dangerous over- and under-doses of insulin for patients using Medtronic’s MiniMed 600 series of insulin pumps qualifies as a high-risk class I recall, the US Food and Drug Administration said on 12 February.

The problem originates with a retainer ring used to lock the insulin cartridge into place in the pump’s reservoir component

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Recalls

More from Policy & Regulation

Access To Library Tools Being Restored At US FDA

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals and laid off librarians have not been reinstated.

FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.