Z-2267-2024Class II

IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100

Name: Z-2267-2024 IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Creator: Angiodynamics, Inc.
Published: 2024-05-21
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-05-21 / Open, Classified / root cause: labeling and UDI

FDA source

Angiodynamics, Inc. began a recall of IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100 on 2024-05-21. FDA classified it as Class II and gives the reason as "A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2267-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-21
Posted: 2024-07-03
Recalling firm: Boston Scientific Corporation
Product: IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Product code: PCT Prostate Immobilizer Rectal Balloon
Reason for recall: A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On May 21, 2024 URGENT VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: IMMEDIATELY: 1. Stop using the product subject to recall. 2. Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). 3. Segregate this product in a secure location for return to AngioDynamics, Inc. 4. Forward a copy of this recall notification to all sites to which you have distributed affected product.
Quantity in commerce: 1,500 units (75 kits with 20 units per kit)
Distribution: US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI.
Product codes and lots: UPN/Catalog: ISO-100; UDI/DI: 10851546007100 (Box) and 00851546007103 (Pouch); Lot number: 5402.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2267-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2267-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03

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)