Medtronic Wire Angio

2021: Recall of 55,000 angiographic microconductors due to poor sterilization

At the end of July 2021, Medtronic Vascular recalled about 55,000 angiographic microconductors that did not undergo proper sterilization before being sent to hospitals. Regulators have classified the recall as Grade I, meaning the problem identified can lead to serious injury or death of the patient. All microwires affected by the recall were on sale from November 2007 to March 2021.

Medtronic Vascular advised customers not to use defective devices designed to install the catheter during intervention procedures. It is recommended that you collect all the products affected by the recall in one place and quarantine them immediately to return or exchange them to Medtronic later.

Medtronic recalls 55 thousand angiographic microconductors due to poor sterilization

Regulators remind that if patients are in contact with a non-sterile device, they may develop serious side effects such as infection, sepsis, and death. Medtronic received two complaints related to non-sterile products, but there were no reports of injuries or fatalities related to this problem. However, there is a possibility of underestimating the problem and its consequences, since doctors did not assume that the devices used were non-sterile, which means they could not connect the occurrence of complications with their use.

Any adverse reactions or quality problems associated with these devices are recommended to be reported to regulators or Medtronic. Angiographic conductors with model numbers WIRE ANGIO 107042 PNS 035X145 3MMJ PTFE (No. 107042), WIRE ANGIO 107044 PNS 038X145 3MMJ 3.0347 PT7047 (T70J ANIO^[1]

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