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U.S. Department of Health and Human Services

Class 2 Device Recall OLYMPUS ViziShot EBUS Aspiration Needle

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 Class 2 Device Recall OLYMPUS ViziShot EBUS Aspiration Needlesee related information
Date Initiated by FirmAugust 25, 2011
Date PostedOctober 07, 2011
Recall Status1 Terminated 3 on September 28, 2012
Recall NumberZ-0029-2012
Recall Event ID 59787
510(K)NumberK050503 
Product Classification kit, needle, biopsy - Product Code FCG
ProductOLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
Code Information Models: NA-201SX-4022-A --22 gauge needle: all lot numbers; NA-201SX-4022-B --22 gauge needle: all lot numbers; NA-201SX-4022-C --22 gauge needle: all lot numbers; and NA-201SX-4021 -- 21 gauge needle: all lot numbers.
Recalling Firm/
Manufacturer		 Olympus America Inc.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley PA 18034-0610
For Additional Information ContactLaura Storms-Tyler
484-896-5688
Manufacturer Reason
for Recall		Firm has received complaints from users of the ability to wipe material from the needle's stylet and the presence of material in patient cytology samples obtained by the needle following endobronchial ultrasound fine needle aspiration of a lesion. Olympus Medical Systems Corporation (OMSC) in Japan has confirmed that metal particles can occur on the stylet due to friction between the stylet and n
FDA Determined
Cause 2		Device Design
ActionOLYMPUS sent an URGENT MEDICAL DEVICE CORRECTION letter dated August 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A revised Instruction Manual with the new WARNINGS will be sent to the customer's attention. Customers were instructed to examine their inventory to determine if they have the affected product. To share the information on the new WARNINGS with all of the appropriate staff at their facility and any other organization where the product has been transferred. Complete and return the enclosed questionnaire even if they do not have affected product. Customers were instructed to fax the completed questionnaire to 484-896-7128. For any question call 484-896-5688.
Quantity in Commerce22,498
DistributionNationwide Distribution including the District of Columbia and the following States: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FCG
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