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U.S. Department of Health and Human Services

Class 2 Device Recall AESCULAP (FH620R) MINOP InVent 30 Trocar System

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  Class 2 Device Recall AESCULAP (FH620R) MINOP InVent 30 Trocar System see related information
Date Initiated by Firm March 07, 2017
Date Posted March 20, 2017
Recall Status1 Terminated 3 on February 16, 2018
Recall Number Z-1814-2017
Recall Event ID 76769
510(K)Number K983365  
Product Classification Endoscope, neurological - Product Code GWG
Product AESCULAP MINOP InVent 30 Trocar System, non-sterile


Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.
Code Information Item # FH620R
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Valerie Strawn
610-984-9414 Ext. 5414
Manufacturer Reason
for Recall		 Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On March 15, 2017, 16 facilities and 1 Sales Rep were sent an Urgent Medical Device Recall Notification letter. Letters were sent Fed-Ex overnight. Customers were asked to immediately discontinue use and quarantine the product. A Sales Representative will remove the affected product and return to Aesculap Inc.
Quantity in Commerce 21 units distributed in U.S.
Distribution Product was distributed throughout the United States and Canada.
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 = GWG and Original Applicant = AESCULAP, INC.
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