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FDA Medical Device Recalls (openFDA)

Merit Medical Systems, Inc.: 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.

Recall number
Z-1731-2010
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.
Status
Terminated
Initiated
2010-05-05
Posted
2010-05-28
Terminated
2010-06-01
Reason
Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands.
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
96 units
Distribution
Nationwide Distribution -- GA, IL, MO, NY, PA and WI.
Lot, serial or model codes
Lot Number: G775032
510(k) numbers
["K000659"]
PMA numbers
not on file
Product code
DQO
Firm FEI
1721504
Firm city
South Jordan
Firm state
UT
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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