Medtronic has recalled certain DLP Left Heart Vent Catheters due to a defect that could cause serious injury or death.
The recall applies to model numbers 12110, 12113 and 12115 with UDI-DIs 20643169880676, 20643169881338 and 20643169880935, according to a Dec. 22 FDA notice. The affected catheters are designed to be malleable and retain a bend in the shaft, but some may not hold their shape as intended.
Medtronic said the defect could lead to abrasion or perforation of critical heart tissue. As of July 28, the company had received three reports of serious injuries but no deaths.
On Aug. 6, Medtronic advised customers to identify, quarantine and return any unused devices. The FDA classified the recall as Class I, its most serious designation.
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