—#125544

Product

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 with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.

FDA product code: MAV — Syringe, Balloon Inflation
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K942269
Affected lot / code info: Lot Number: 50755851

Why it was recalled

Incorrect master label.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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 affected product has been forwarded to another facility, customers were asked to notify that facility accordingly and facilitate the retrieval of the affected product. Customers with questions were instructed to contact their Medtronic representative. For questions regarding this recall call 888-283-7868.

Recalling firm

Firm: Medtronic Vascular
Address: 35-37A Cherry Hill Drive, Danvers, Massachusetts 01923-2565

Distribution

Distribution pattern: Nationwide Distribution including TX, ME, IA, PA, OR, and NH.

Timeline

Recall initiated: 2014-02-06
Posted by FDA: 2014-02-26
Terminated: 2014-06-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125544. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.