Z-0742-2018Class II

Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number...

Name: Z-0742-2018 Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number...
Creator: Angiodynamics, Inc.
Published: 2017-09-22
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-09-22 / Terminated / root cause: manufacturing process

FDA source

Angiodynamics, Inc. began a recall of Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are... on 2017-09-22. FDA classified it as Class II and gives the reason as "Product was placed into distribution prior to completion of all required post sterilization release activities". 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-0742-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-22
Posted: 2018-02-13
Terminated: 2018-09-19
Recalling firm: Boston Scientific Corporation
Product: Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Product was placed into distribution prior to completion of all required post sterilization release activities.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were contacted by phone and by a letter sent via Federal Express. Consignees were instructed to stop using product, segregate affected product, and return the product to the firm along with a reply verification tracking form. For further questions, please call (518) 795-1676.
Quantity in commerce: 28
Distribution: US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.
Product codes and lots: Lot Number: 5229642; Manufactured 6-Sep-17; Expiration Date: 31-Aug-20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0742-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0742-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27

Product code DQO

K112452Class IIAngiodynamics Soft-Vu Angiographic CathetersAngioDynamics, Inc. / cleared 2012-03-30

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)