Z-1707-2010

PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERILE, EO...

Name: Z-1707-2010 PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERILE, EO...
Creator: Angiodynamics, Inc.
Published: 2010-05-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-05-17 / Terminated / root cause: manufacturing process

FDA source

Angiodynamics, Inc. began a recall of PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERILE, EO. AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804... on 2010-05-17. The reason FDA records is "This lot was packaged with the wrong occluding ball guidewire. The PulseSpray Catheter is 90 cm in length and requires a 109 cm occluding ball guidewire, however this lot was packaged with a 60 cm occluding ball...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1707-2010
Status: Terminated
Initiated: 2010-05-17
Posted: 2010-05-27
Terminated: 2012-07-25
Recalling firm: Boston Scientific Corporation
Product: PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERILE, EO. AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804. Infusion Catheter.
Product code: KRA Catheter, Continuous Flush
Reason for recall: This lot was packaged with the wrong occluding ball guidewire. The PulseSpray Catheter is 90 cm in length and requires a 109 cm occluding ball guidewire, however this lot was packaged with a 60 cm occluding ball guidewire.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Angiodynamics issued an "Urgent Medical Device Recall" notification (dated 5/11/10) to user accounts via Certified Mail. Consignees were asked to identify, segregate and return all affected product to the firm in addition to sending in a completed Reply Form via fax. For further information, contact Angiodynamics Customer Service at 1-800-772-6446.
Quantity in commerce: 20 units
Distribution: Worldwide Distribution -- United States (AR, NY, PA, MI, MN, LA and WA), Spain, Austria and Denmark.
Product codes and lots: Lot Number: 991437.

Product code KRA

K905447Class IIE-Z-Em Pulsed Infusion SystemE-Z-Em, Inc. / cleared 1991-04-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)