PulseSpray recallZ-1010-2024 · Angiodynamics, Inc. · initiated Dec 18, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Angiodynamics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
FDA root cause category: Process control
What the company is doing
An Urgent Medical Voluntary Medical Device notices dated December 18, 2023 was issued to distributors and end users with instructions to immediately stop using affected product, remove said product from inventory and return to AngioDynamics, Inc. The notice should be forwarded to all site affected product may have been distributed to and recipients are asked to 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.
Recall details
- Recall number
- Z-1010-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 18, 2023
- Posted by the FDA
- Feb 7, 2024
- Recalling firm
- Angiodynamics, Inc.
- Quantity
- 7 eaches
- Product code
- KRA
- FDA submissions
- K163356
- Distribution
- United States (MD, LA & UT), Austria, Canada and Spain.
Product description
PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.
Code information (models, lots, serial numbers)
UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345; UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480; UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- PulseSpray H787125004040Angiodynamics, Inc. · Catheter, continuous flush1 recall0 reports
- PulseSpray H787125004150Angiodynamics, Inc. · Catheter, continuous flush1 recall0 reports
- PulseSpray H787125004230Angiodynamics, Inc. · Catheter, continuous flush1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K163356 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- UniFuse 12401822Angiodynamics, Inc. · Catheter, continuous flush1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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