Official recall record

Pulse*Spray® Infusion Systems 3fx135x120

What the authority reported

Angiodynamics, Inc., is conducting a medical device recall to the end user level based on information received from ICU medical (Smith Medical), the manufacturer of the non-sterile high-pressure rotator which are components of the sterile Angiodynamics Pulse*Spray® Infusion Catheter Systems. ICU medical has determined that specific non-sterile high-pressure rotator lots, listed in their supplier notification dated November 16, 2023, contain a manufacture defect. As stated in the information provided by ICU medical, "The inner diameter of the device's [rotating adaptor's] o-ring may be oversized affecting seal integrity." Angiodynamics has confirmed that the affected Pulse*Spray® Infusion Systems were distributed to end users located in the United States, Europe, and Canada. Angiodynamics began distributing Pulse*Spray® Infusion Systems affected by this recall globally on August 29, 2023. Angiodynamics has not received any complaints associated with the affected Pulse*Spray® Infusion Systems or reports of patient injury as a result of this issue. Recall start date: December 18, 2023

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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