Z-1010-2024Class II

PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse...

Name: Z-1010-2024 PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse...
Creator: Angiodynamics, Inc.
Published: 2023-12-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2023-12-18 / Open, Classified / root cause: manufacturing process

FDA source

Angiodynamics, Inc. began a recall of PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF... on 2023-12-18. FDA classified it as Class II and gives the reason as "Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication". 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-1010-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-18
Posted: 2024-02-07
Recalling firm: Boston Scientific Corporation
Product: 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.
Product code: KRA Catheter, Continuous Flush
Reason for recall: Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 7 eaches
Distribution: United States (MD, LA & UT), Austria, Canada and Spain.
Product codes and lots: UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345; UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480; UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1010-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1010-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-07

Product code KRA

K163356Class IIPulse* Spray Infusion System, Uni*Fuse Infusion SystemAngioDynamics, Inc. / cleared 2017-05-30

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)