The US Food and Drug Administration have issued a Class I Recall of the SoloPath (Terumo Medical) ballon-expandable transfemoral system and re-collapsible balloon access system, due to malfunction. A total of 14 reports had flagged related incidents of a specific device malfunction, including two injures. No deaths have been reported, the FDA notes.
The malfunction issue, the FDA recall announcement states, is a potential for dislodgement of the fairing tip from the sheath, hindering the smooth transition of the device through the body. This malfunction could make the device unable to transition through the skin to the iliac artery, or cause dissection, false lumen, pseudoaneurysm, haemorrhage, vessel perforation and vessel disruption, which in turn may result in additional interventions, increased procedure time, or death.
In April 2019, Terumo issued a voluntary recall and listed the following recommended actions:
- Review the Product Recall Bulletin and the Required Actions.
- Assure that all users receive notice of this issue so that required actions can be performed.
- Assure that this notice is forwarded to applicable facilities if any affected products were further distributed outside of your facility.
- Review your SOLOPATH inventory immediately to identify and isolate affected inventory to prevent future use.
- Complete the Medical Device Recall Response Form. The form is required even if you do not have product to return.
- If you have product to return, contact Stericycle to obtain a credit and reference event number 10082. Phone Number: 855-205-2627 E-Mail: return to firstname.lastname@example.org.
- E-mail the Recall Acknowledgement Form to email@example.com to arrange for product to be returned to Stericycle.
Terumo encourages customers to consider alternative suppliers.
Read the full FDA recall notice here.