The U.S. Food and Drug Administration (FDA) has released a critical early alert regarding certain Medline Convenience Kits, which may contain potentially hazardous Medtronic DLP Left Heart Vent Catheters. Both clinical and regulatory teams are urged to evaluate their stock and take appropriate action to mitigate patient risk.
What changed?
On August 21, 2025, Medline issued an urgent communication to notify customers about a recall involving specific lots of Medline Kits containing Medtronic DLP Left Heart Vent Catheters. The devices in question were identified to have shape retention issues, with 41 complaints logged as of July 28, 2025. These include three cases of patient injury due to tissue perforation, while other complaints involved procedure prolongation with no direct patient harm. Although no fatalities have been reported, the risks of device-related complications remain significant.
Who is affected?
The recall primarily impacts healthcare facilities and distributors who have purchased Medline Convenience Kits containing the affected Medtronic DLP Left Heart Vent Catheters. These catheters are typically employed during cardiopulmonary bypass surgeries to vent the left heart for durations under six hours. Both direct customers and entities that have resold or transferred these products must take immediate compliance actions.
Why are these devices being recalled?
The recall stems from an identified issue with shape retention in specific catheter lots. Shape retention is critical for safe and effective device use. Affected devices may cause unintended tissue abrasion or perforation during use—a complication that, if unnoticed and untreated, poses serious risks, including potential death. For procedures interrupted before the device is used, patients may experience delays while replacement devices are sourced.
Manufacturer reports
According to Medtronic, the manufacturer of the DLP Left Heart Vent Catheters, three injuries and no deaths have been linked to this issue as of the last update on July 28, 2025. Medline and Medtronic are coordinating efforts to ensure all customers take the recommended actions.
Necessary actions for stakeholders
All healthcare providers and distributors should follow these steps to ensure compliance with the recall:
- Immediately check your stock against the listed affected item numbers and lot numbers.
- Quarantine any affected products found in your inventory.
- Complete and submit the response form available in the recall portal.
- Destroy all affected products after completing the necessary documentation.
Distributors must inform all downstream customers of this recall and include their customers’ quantities in their response forms. Medline has provided a recall reference number (R-25-181-FGX1) and a dedicated response portal at https://recalls.medline.com.
How to report adverse events
Patients or healthcare professionals experiencing complications related to these devices are encouraged to report issues through the FDA’s MedWatch program. Adverse event reports are critical for tracking device performance and enhancing patient safety. For further questions, Medline can be contacted at 866-359-1704 or recalls@medline.com.
Conclusion
This recall highlights the importance of vigilance in medical device procurement and usage. Stakeholders must act quickly to identify, quarantine, and dispose of affected Medline Kits to prevent procedural delays or adverse outcomes. The FDA is continuing to monitor this situation and will update the public as new information becomes available.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or medical advice. Always refer to official FDA communications and consult with regulatory experts for compliance questions.