Dive Brief:
- Medtronic has recalled cardiac catheters because of a problem cited in three reports of serious injuries.
- The Food and Drug Administration published an early alert about the removal of the products Friday, after Medtronic sent a letter to customers on Aug. 6.
- Medtronic asked customers to quarantine three models over reports of problems shaping the malleable materials. The issues could delay procedures or cause cuts to heart tissue.
Dive Insight:
Medtronic wrote to customers about 232 lots of its DLP Left Heart Vent Catheters. Physicians use the devices to vent the left heart for up to six hours during cardiopulmonary bypass procedures.
The FDA said the request to quarantine the devices followed reports of the products “resisting shape retention when being bent.” Medtronic designed the devices to be malleable and retain a bend in the shaft.
The FDA said the failure of devices to keep their shape could delay surgeries while a replacement device is found. If a faulty device is used, the cannula could cut heart tissue, the agency said.
There have been no reports of deaths linked to the problem but the FDA said a cut to critical heart tissue could be fatal “if it is complicated, unnoticed or untreated.” The possible harms led the agency to include Medtronic’s action in an FDA pilot program for providing early alerts about potentially high-risk issues.
Medtronic told customers that it has corrected the issue for newly manufactured devices but will have “limited product availability” over the next few months.
The company is asking users who are unable to access stock to work with their sales representatives to explore other devices. Medtronic will issue a credit note if no suitable replacement is available.
