Delfi Medical Innovations, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1902-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile

Product Classification:

Class II

Date Initiated: April 3, 2019

Date Posted: May 13, 2020

Recall Number: Z-1902-2020

Event ID: 84741

Reason for Recall:

Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimeter weld on the cuff. Once applied to a patients thigh and inflated to a pressure to occlude blood flow in the thigh distal to the cuff, after a period of time the cuff may leak to the extent that the tourniquet instrument supplying air pressure to the cuff may not be able to adequately control and regulate pressure in the cuff. This may result in some blood flow in the thigh distal to the cuff.

Status: Terminated

Product Quantity: 24 units

Code Information:

18J15

Distribution Pattern:

US: Ohio OUS: Austrailia

Voluntary or Mandated:

Voluntary: Firm initiated