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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

Soft-Vu and AccuVu Angiographic Catheters Recalled for Manufacturing Defect

Agency Publication Date: April 17, 2026
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Summary

Angiodynamics, Inc. is recalling approximately 24,335 Soft-Vu and AccuVu Angiographic Catheters due to a manufacturing defect that may block the catheter's internal path. This defect can prevent appropriately sized guidewires from passing through the catheter hub during medical procedures. While no injuries have been reported, the issue affects 20 specific product models distributed worldwide between March 2025 and March 2026. Healthcare providers and facilities should immediately stop using the affected lots and contact the manufacturer to arrange for their return.

Risk

The defect creates a physical obstruction within the catheter hub that prevents the insertion of surgical guidewires. This can lead to procedure delays, the need for additional medical interventions, or potential vascular injury if force is used to overcome the obstruction.

What You Should Do

  1. Identify your device by checking the product name, catalog number, and lot number on the box or pouch packaging.
  2. Check for affected Soft-Vu models (Catalog Nos. 10707103, 10710013, 10714001, 10714002, 10714009, 10714011, 10714014, 10714016, 10714017, 10714018, 10714021, 10714024, 10714040, 10731401, 10732301, 10734301). See the Affected Products section below for the full list of affected codes.
  3. Check for affected AccuVu models (Catalog Nos. 13709005, 13709604, 13709704, 13709804). See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Soft-Vu Angiographic Catheter, Pigtail, Non-Braided
Variants: 4F X 100CM, 035 NB 10SH
Model / REF:
10707103
Lot Numbers:
A3325043
UDI:
25051684006177
15051684006170

Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch)

Product: Soft-Vu Angiographic Catheter, Kumpe, Non-Braided
Variants: 4F X 40CM, 038 NB 0SH
Model / REF:
10710013
Lot Numbers:
A3625012
A3825055
UDI:
25051684007440
15051684007443

Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch)

Product: Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided
Variants: 4F X 65CM, 038 NB 6SH
Model / REF:
10714001
Lot Numbers:
A2425078
A3325036
A3525030
A3525031
A3725102
UDI:
25051684007778
15051684007771

Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch)

Product: Soft-Vu Angiographic Catheter, Pigtail, Non-Braided
Variants: 4F X 65CM, 038 NB 10SH
Model / REF:
10714002
Lot Numbers:
A2525060
A2525061
A3625006
A3625007
UDI:
25051684007785
15051684007788

Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch)

Product: Soft-Vu Angiographic Catheter, Berenstein, Non-Braided
Variants: 4F X 65CM, 038 NB 0SH
Model / REF:
10714009
Lot Numbers:
A2825134
A2825153
A3825063
UDI:
25051684007853
15051684007856

Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch)

Product: Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided
Variants: 4F X 65CM, 038 NB 0SH
Model / REF:
10714011
Lot Numbers:
A3025038
A3025051
UDI:
25051684007877
15051684007870

Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch)

Product: Soft-Vu Angiographic Catheter, Kumpe, Non-Braided
Variants: 4F X 65CM, 038 NB 0SH
Model / REF:
10714014
Lot Numbers:
A2825033
A2825034
A2825132
A2825133
A3725048
A3725049
UDI:
25051684007891
15051684007894

Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch)

Product: Soft-Vu Angiographic Catheter, Berenstein, Non-Braided
Variants: 4F X 100CM, 038 NB 0SH
Model / REF:
10714016
Lot Numbers:
A2525098
UDI:
25051684007914
15051684007917

Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch)

Product: Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided
Variants: 4F X 100CM, 038 NB 0SH
Model / REF:
10714017
Lot Numbers:
A2425089
UDI:
25051684007921
15051684007924

Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch)

Product: Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided
Variants: 4F X 100CM, 038 NB 0SH
Model / REF:
10714018
Lot Numbers:
A2825145
UDI:
25051684007938
15051684007931

Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch)

Product: Soft-Vu Angiographic Catheter, Kumpe, Non-Braided
Variants: 4F X 100CM, 038 NB 0SH
Model / REF:
10714021
Lot Numbers:
A2525059
A3725003
A3725004
UDI:
25051684007952
15051684007955

Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch)

Product: Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided
Variants: 4F X 80CM, 038 NB 0SH
Model / REF:
10714024
Lot Numbers:
A2825152
A3225009
UDI:
25051684007983
15051684007986

Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch)

Product: Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided
Variants: 4F X 100CM, 038 NB 0SH
Model / REF:
10714040
Lot Numbers:
A2725049
UDI:
25051684008102
15051684008105

Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch)

Product: Soft-Vu Angiographic Catheter, Straight Art, Non-Braided
Variants: 4F X 65CM, 035 NB 0SH
Model / REF:
10731401
Lot Numbers:
A2825042
UDI:
25051684009475
15051684009478

Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch)

Product: Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided
Variants: 4F X 65CM, 035 NB 6SH
Model / REF:
10732301
Lot Numbers:
A2825022
A3025035
A3025037
UDI:
25051684009727
15051684009720

Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch)

Product: Soft-Vu Angiographic Catheter, Kumpe, Non-Braided
Variants: 4F X 40CM, 035 NB 0SH
Model / REF:
10734301
Lot Numbers:
A2825021
A2825129
A3325027
A3425027
A3525014
A3825095
UDI:
25051684010112
15051684010115

Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch)

Product: AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers
Variants: 4F X 70CM, 035 NB 6SH 2 R/O 2CM
Model / REF:
13709005
Lot Numbers:
A2725033
A2725034
A3525048
A3525049
UDI:
25051684005712
15051684005715

Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch)

Product: AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers
Variants: 4F X 100CM, 035 NB 6SH 10 R/O 6@1CM 4@5CM
Model / REF:
13709604
Lot Numbers:
A2825044
UDI:
25051684005996
15051684005999

Product/UPN No.: H787137096045 (Box), H787137096040 (Pouch)

Product: AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers
Variants: 4F X 70CM, 035 NB 6SH 21 R/O 1CM
Model / REF:
13709704
Lot Numbers:
A3025039
A3225033
UDI:
25051684006030
15051684006033

Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch)

Product: AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers
Variants: 4F X 70CM, 035 NB 10SH 21 R/O 1CM
Model / REF:
13709804
Lot Numbers:
A2825131
UDI:
25051684006085
15051684006088

Product/UPN No.: H787137098045 (Box), H787137098040 (Pouch)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98463
Status: Active
Manufacturer: Angiodynamics, Inc.
Sold By: Medical distributors
Manufactured In: United States
Units Affected: 24,335
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.