Z-0411-2020Class II

Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as...

Name: Z-0411-2020 Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as...
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2019-10-02
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2019-10-02 / Terminated / root cause: labeling and UDI

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part... on 2019-10-02. FDA classified it as Class II and gives the reason as "The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0411-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-02
Posted: 2019-11-15
Terminated: 2020-07-29
Recalling firm: Boston Scientific Corporation
Product: Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On October 2, 2019, AngioDynamics initiated a recall action by contacting customers by telephone and directing them to stop using the affected product and segregate until receipt of written the written recall notification. URgent Voluntary Medical Device Recall notification letters were sent to these customers on October 8, 2019. 1. Actions to be taken: " IMMEDIATELY o Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). o Segregate this product in a secure location for return to AngioDynamics, Inc. o Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. " If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800- 772-6446 between 8:00 a.m. and 7:00 p.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 Tracking Form. Email Reply Verification Tracking Form (preferred): [email protected] Fax Reply Verification Tracking Form: Attn: Talon Semi-Flex Recall Coordinator Fax number 1-800-782-1357 3. Package and Return the Recalled Product. " Package any product that is being returned in an appropriate shipping box. " Write the RMA number on the RMA/Address label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. " To request a shipping label for returning product, please contact Customer Service (via recall email address) for a prepaid FedEx label. " Seal the box and return to: AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804 Attn: T
Quantity in commerce: 30
Distribution: The products were distributed to the following US states: LA, MA, OR, VA, and WA.
Product codes and lots: Lot 5476032

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0411-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0411-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-15

Product code GEI

K010060Class IIRita Starburst Xli Electrosurgical DeviceRita Medical Systems / cleared 2001-01-23

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)