Recall Z-1121-2014 ยท MAV Syringe, Balloon Inflation
Medtronic Vascular
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted
| Date | Feb 26, 2014 (initiated Feb 6, 2014) |
| Status | Terminated |
| Reason | Incorrect master label. |
| Root cause | Labeling mix-ups |
| Action | Medtronic sent an Urgent Medical Device Recall letter on February 6, 2014, via UPS 3-day delivery. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product that remains in their inventory. Return the affected product to Medtronic: Contact Customer Service at 888-283-7868 and reference RADAR # 170276 to initiate a return and credit of product. Complete the attached Customers Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. If any affecte |
| Quantity | 191 devices |
| Distribution | Nationwide Distribution including TX, ME, IA, PA, OR, and NH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942269 | MEDTRONIC EVEREST INFLATION DEVICE Medtronics Interventional Vascular, Oct 18, 1994 |