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U.S. Department of Health and Human Services

Class 2 Device Recall VIPA IntraFiberoptic Pelvic Assistant

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 Class 2 Device Recall VIPA IntraFiberoptic Pelvic Assistantsee related information
Date Initiated by FirmApril 09, 2009
Date PostedMarch 25, 2010
Recall Status1 Terminated 3 on September 03, 2010
Recall NumberZ-1206-2010
Recall Event ID 53501
Product Classification Probe, Rectal, Non-Powered - Product Code EXX
ProductVIPA Veronikis Intra-Fiberoptic Pelvic Assistant, Set Catalog No 350-370. VIPA Set Includes: VIPA Urethropexy Tip Catalog No. 350-374 (Also sold individually); VIPA Urethropexy Elbow Catalog No. 350-375 (also sold individually); VIPA Vaginal Cuff Tips (small) Catalog No. 350-376 (Also sold individually); VIPA Vaginal Cuff Tips (large) Catalog No. 350-378 (Also sold individually); VIPA Rectal Probe Catalog No. 350-380 (Also sold Individually); VIPA Fiber Optic Cable (Storz to ACMI Connection) Catalog No. 350-372 (Also sold individually). For use in Urethropexy Procedures and Paravaginal Repairs (accurate suture placement by illuminating the anatomy lateral to the bladder neck); in Sacrocolpopexy (steadies the vaginal vault and provides a suture platform with fiberoptic illumination); in Vaginal surgery (illuminates the rectum to visualize endometriosis lesions on the rectovaginal septum).
Code Information KIT Catalog No. 350-370 Individually Catalog No 350-374; 350-375; 350-376; 350-378; 350-380; 350-372.
Recalling Firm/
Manufacturer		 Marina Medical Instruments Inc.
955 Shotgun Rd
Sunrise FL 33326-1964
For Additional Information ContactLisa Barron
954-924-4418
Manufacturer Reason
for Recall		Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary skin or tissue irritation.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionA "PRODUCT RECALL NOTICE" letter dated April 8, 2009, was sent to the customers. The letter describes the product, problem and the action to be taken by the customers. The customers are asked to identify the subject part in their instrument inventory and quarantine it. The Quality Control team at Marina Medical will contact the customer with instructions to return the part. When contacted, the customer should report any incidents of adverse reactions that have been observed at their institution. If you have any questions, please call 1-800-697-1119 ore (954) 924-4418.
Quantity in Commerce47
DistributionNationwide distribution.
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.
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