Z-1143-2015Class II

Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog...

Name: Z-1143-2015 Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog...
Creator: Angiodynamics
Published: 2014-12-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2014-12-19 / Terminated

FDA source

Angiodynamics began a recall of 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... on 2014-12-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1143-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Posted: 2015-02-24
Terminated: 2015-11-27
Recalling firm: Boston Scientific Corporation
Product: 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
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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: Other
Action: 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.
Quantity in commerce: 43
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 codes and lots: Lot No. 4773676, 4776428 and 4780110

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1143-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1143-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-24

Product code GEI

K992693Class IIRita Model 90 Electrosurgical Accessory, Model 90Rita Medical Systems / cleared 1999-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)