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U.S. Department of Health and Human Services

Class 3 Device Recall Medtronic Everest 20cc Inflation Device

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  Class 3 Device Recall Medtronic Everest 20cc Inflation Device see related information
Date Initiated by Firm February 06, 2014
Date Posted February 26, 2014
Recall Status1 Terminated 3 on June 02, 2014
Recall Number Z-1121-2014
Recall Event ID 67490
510(K)Number K942269  
Product Classification Syringe, balloon inflation - Product Code MAV
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.
Code Information Lot Number: 50755851
Recalling Firm/
Manufacturer		 Medtronic Vascular
35-37A Cherry Hill Drive
Danvers MA 01923-2565
For Additional Information Contact
888-283-7868
Manufacturer Reason
for Recall		 Incorrect master label.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 191 devices
Distribution Nationwide Distribution including TX, ME, IA, PA, OR, and NH.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAV and Original Applicant = MEDTRONICS INTERVENTIONAL VASCULAR
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