Prostate Treatment Balloons Recalled Due to Fill Volume Mislabeling
Angiodynamics is recalling IsoLoc Prostate Immobilization Balloons (ISO-100, Lot 5402) for mislabeling. Devices have 100cc fill volume but are labeled as ISO-60 (60cc).
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with mislabeling that creates a risk-of-harm situation. The fill-volume discrepancy (100cc labeled as 60cc) could affect clinical accuracy and patient safety. No illnesses or injuries have been reported, per the rubric limitation that risk-of-harm without reported injury scores at most 3.
Plain-English summary
Angiodynamics, Inc. is recalling IsoLoc Prostate Immobilization Treatment Balloon Device Kits (Catalog ISO-100, Lot 5402) due to mislabeling of fill volume. The affected balloon catheters have a nominal fill volume of 100 cubic centimeters (cc), but the inner pouch identifies them as ISO-60 units with a 60cc fill volume.
This mislabeling discrepancy creates a risk of improper clinical administration if the wrong fill volume is used during treatment. The affected devices were distributed nationwide to healthcare facilities in Arizona, Florida, Illinois, Missouri, Mississippi, New Jersey, New Mexico, New York, Pennsylvania, Texas, and Wisconsin.
Healthcare providers who have received these devices from Lot 5402 should stop using them and contact Angiodynamics immediately. Do not use affected units without verification that the actual fill volume matches clinical requirements.
The recalled product
- Product
- IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
- Manufacturer
- Angiodynamics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UPN/Catalog: ISO-100
- UDI/DI: 10851546007100 (Box) and 00851546007103 (Pouch)
- Lot number: 5402.
Distribution
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