Recall Z-0877-2015 ยท MAV Syringe, Balloon Inflation
PEROUSE MEDICAL
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter
| Date | Dec 29, 2014 (initiated Oct 6, 2014) |
| Status | Terminated |
| Reason | Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure |
| Root cause | Device Design |
| Action | Perouse Medical notified Distributors by Safety Alert Letter sent on October 06, 2014 and and October 07, 2014 by e-mail. The letter identified the defective products and lot numbers and provided a description of the malfunction, risk and mitigation statements. US distributors have been requested to provide the required information to their customers. In addition, the firm has updated device instructions for use. The firm is requiring its customer to fill out a safety notice acknowledgement of receipt form. |
| Quantity | 2184 units |
| Distribution | US Nationwide Distribution in the states of AZ and CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110604 | VBB SYSTEM Synthes, Dec 13, 2011 |