Z-1391-2025Class II

IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60

Name: Z-1391-2025 IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60
Creator: Angiodynamics, Inc.
Published: 2025-02-04
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2025-02-04 / Open, Classified / root cause: manufacturing process

FDA source

Angiodynamics, Inc. began a recall of IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60 on 2025-02-04. FDA classified it as Class II and gives the reason as "Product is mislabeled with the incorrect fill volume". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1391-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-04
Posted: 2025-03-18
Recalling firm: Boston Scientific Corporation
Product: IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Product code: PCT Prostate Immobilizer Rectal Balloon
Reason for recall: Product is mislabeled with the incorrect fill volume.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 4, 2025, URGENT VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. ACTIONS TO BE TAKEN BY CONSIGNEES OF THE RECALL NOTIFICATION 1. IMMEDIATELY - Stop using the product subject to recall. - Remove any affected (recalled) 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. - 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. - 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: 1-855-273-0519 (Fax #) Attn: ISO-60 Recall Coordinator - Call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 6:00 p.m. EST (Monday Friday) to obtain a replacement or credit for your returned product. - Report any Adverse reactions or quality problems associated with recalled devices to US FDA via MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 3. Package and Return the Recalled Product. - Package any product that is being returned in an appropriate shipping box. - Write the RMA number (provided on the Recall Verification Tracking Form) on the RMA reference sticker and affix the sticker to the outside of the shipping box. - Contact AngioDynamics Inc. by phone or email (above contact) for shipping labels for returning the device. - Seal the box and return to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: ISO-60 Recall Coordinator
Quantity in commerce: 1,800 units
Distribution: US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.
Product codes and lots: UPN/Catalog Number: ISO-60; UDI-DI: 00851546007219; Batch/Lot No.: 5694;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1391-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1391-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-18

Product code PCT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)