1. Medtech Insight
  2. >>Archive

Medtronic drug delivery warning gets class I stamp

Medtronic's warning to physicians that its implantable intrathecal drug delivery systems could present a potential risk to patients has been labelled as a class I recall by the US FDA. The Minneapolis, Minnesota-based company received the highest possible recall caution after it informed professionals via a letter in January 2008 that patients receiving therapy through its SynchroMed and IsoMed infusion systems had seen an increase in the rate of reported inflammatory mass cases. The letter, which was an update on communications the company had made in 2001 and 2003, stated that the reported cases of inflammatory mass in intrathecal drug delivery patients had risen from 0.1% in 2001 to 0.5% in 2007. Medtronic said that true incidence rate, which is currently unknown, could be even higher than 0.5% due to under-reporting.

Medtronic's warning to physicians that its implantable intrathecal drug delivery systems could present a potential risk to patients has been labelled as a class I recall by the US FDA. The Minneapolis, Minnesota-based company received the highest possible recall caution after it informed professionals via a letter in January 2008 that patients receiving therapy through its SynchroMed and IsoMed infusion systems had seen an increase in the rate of reported inflammatory mass cases. The letter, which was an update on communications the company had made in 2001 and 2003, stated that the reported cases of inflammatory mass in intrathecal drug delivery patients had risen from 0.1% in 2001 to 0.5% in 2007. Medtronic said that true incidence rate, which is currently unknown, could be even higher than 0.5% due to under-reporting.

The company said that no deaths connected with this issue had been reported, although it did state that frequent symptoms...

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 Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

More from Medtech Insight

Cardiology And PTA Procedures In Germany’s Expanded Hybrid DRGs List 2026

 
• By Ashley Yeo

2026 reimbursement calculations for the list of hybrid DRGs – a mechanism to incentivize day cases over inpatient surgery – will be issued in few weeks’ time. The medtech industry has made its demands known.

Deals Shaping The Medtech And Diagnostics Industries, July 2025

 
• By Medtech Insight Team

An interactive look at medtech and diagnostics deals made during July 2025. Data courtesy of Biomedtracker.

Biden-Era Device Trial Snapshot Pilot Halted Amid DEI Policy Shift

 
• By Elizabeth Orr

The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.