Z-1731-2010

Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit...

Name: Z-1731-2010 Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit...
Creator: Merit Medical Systems, Inc.
Published: 2010-05-05
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2010-05-05 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095... on 2010-05-05. The reason FDA records is "Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands". 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-1731-2010
Status: Terminated
Initiated: 2010-05-05
Posted: 2010-05-28
Terminated: 2010-06-01
Recalling firm: Merit Medical Systems, Inc.
Product: Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Merit Medical Systems, Inc. began notifying sales representatives beginning May 5, 2010 via phone and instructed to contact all of their affected accounts. All affected product was to be returned to the firm. For further information, contact Merit Medical at 1-713-757-5067 or 1-801-208-4468.
Quantity in commerce: 96 units
Distribution: Nationwide Distribution -- GA, IL, MO, NY, PA and WI.
Product codes and lots: Lot Number: G775032

Product code DQO

K000659Class IIModification to Softouch Diagnostic Intravascular CatMerit Medical Systems, Inc. / cleared 2000-03-29

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)