Medtronic Warns About Certain Left Heart Vent Catheters

The FDA provided a notice that Medtronic sent a letter to affected customers recommending that certain DLP left heart vent catheters be removed from where they’re used or sold.

Medtronic had received reports of the affected product resisting shape retention when being bent. The catheters are meant to be malleable and retain a bend in the shaft. It’s intended for use in venting the left heart during cardiopulmonary bypass surgery up to six hours or less.

When the issue is identified before use, it can lead to procedure delay while another cannulae is located. If not identified before use and the clinician uses the cannula, it can lead to abrasion and perforation. Perforating critical heart tissue can lead to death if it’s complicated, unnoticed, or untreated.

As of July 28, Medtronic reported three serious injuries and no deaths related to the issue with its left heart vent catheters.

Customers should review inventory for the listed product and immediately identify and quarantine all unused, listed product in their inventory. Medtronic said the issue was corrected for newly manufactured lots, but said customers should be aware that it will have limited product availability for these items over the next few months.

If the product in unavailable, the company advised working with a sales representative to explore potential replacement options it can offer. Alternatively, the company said it will issue a credit note if a suitable replacement isn’t available.

Affected devices