FDA Medical Device Recalls (openFDA)
Marina Medical Instruments Inc.: VIPA 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).
- Recall number
- Z-1206-2010
- Recalling firm
- Marina Medical Instruments Inc.
- Product
- VIPA 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).
- Status
- Terminated
- Initiated
- 2009-04-09
- Posted
- 2010-03-25
- Terminated
- 2010-09-03
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- A "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
- 47
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- KIT Catalog No. 350-370 Individually Catalog No 350-374; 350-375; 350-376; 350-378; 350-380; 350-372.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EXX
- Firm FEI
- 1000124817
- Firm city
- Sunrise
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28