Starburst MRI Semi-Flex Electrode Device, 25cm/Attached… recallZ-1143-2015 · Angiodynamics · initiated Dec 19, 2014
Class II Terminated All recalls posted in February 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Angiodynamics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle.
FDA root cause category: Other
What the company is doing
AngioDynamics sent an Urgent Medical Device Recall - Immediate Action Required letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Immediately remove the recall product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). Segregate this product in a secure location for return to AngioDynamics, Inc. Immediately forward a copy of this recall notification to all sites to which you have distributed affected product. If affected product is located in your institution, please call AngioDynamics, Inc. Customer Service at 1-800-772-6446 between 8:00a.m. and 7:00p.m. (Monday- Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return) following the directions on this page and the Reply Verification Form.
Recall details
- Recall number
- Z-1143-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 19, 2014
- Posted by the FDA
- Feb 24, 2015
- Recalling firm
- Angiodynamics
- Quantity
- 43
- Product code
- GEI
- FDA submissions
- K992693
- Distribution
- Worldwide Distribution - US Distribution to the states of AZ, AR, FL, MI, MN, MO, NY, TX, VA, WA and WI., and to the countries of Hungary and Spain.
Product description
Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615
Code information (models, lots, serial numbers)
Lot No. 4773676, 4776428 and 4780110
Other devices under the same FDA submission
5 devices cleared under K992693 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- StarBurst 700-101930Navilyst Medical, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- StarBurst 700-101320Navilyst Medical, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- StarBurst 700-103902Navilyst Medical, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- StarBurst 700-103903Navilyst Medical, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- StarBurst 700-103905Navilyst Medical, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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