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FDA recall, , Moderate risk

Angiodynamics AccuVu and Soft-Vu Angiographic Catheter

A manufacturing defect may prevent the guidewire from passing through the catheter hub.

Summary by Recall Canary from the FDA notice

What happened

Angiodynamics, Inc. of Queensbury, New York, recalled multiple AccuVu and Soft-Vu Angiographic Catheters because a manufacturing defect may prevent the appropriately sized guidewire from passing through the inner diameter of the catheter hub. The company began the recall on March 3, 2026, and the FDA added it to its Enforcement Report on April 17, 2026.

The devices were distributed worldwide, including nationwide in the US and in countries such as Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, and Thailand.

More manufacturing problem recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Product details

    AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers;
    ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM;
    Catalog No.: 13709604;
    Product/UPN No.: H787137096045 (Box), H787137096040 (Pouch);
    Box Quantity: 5 pouches;

    UDI-DI
    • 13709604
    • 25051684005996
    • 15051684005999
    Lot code
    • A2825044

  2. Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; Soft-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;

    UDI-DI
    • 10714014
    • 25051684007891
    • 15051684007894
    Lot code
    • A2825033
    • A2825034
    • A2825132
    • A2825133
    • A3725048
    • A3725049

  3. Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; Soft-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;

    UDI-DI
    • 10714021
    • 25051684007952
    • 15051684007955
    Lot code
    • A2525059
    • A3725003
    • A3725004

  4. Product details

    AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers;
    ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM;
    Catalog No.: 13709005;
    Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch);
    Box Quantity: 5 pouches;

    UDI-DI
    • 13709005
    • 25051684005712
    • 15051684005715
    Lot code
    • A2725033
    • A2725034
    • A3525048
    • A3525049

  5. Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; Soft-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;

    UDI-DI
    • 10714016
    • 25051684007914
    • 15051684007917
    Lot code
    • A2525098

  6. Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; Soft-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;

    UDI-DI
    • 10714002
    • 25051684007785
    • 15051684007788
    Lot code
    • A2525060
    • A2525061
    • A3625006
    • A3625007

  7. Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; Soft-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;

    UDI-DI
    • 10714009
    • 25051684007853
    • 15051684007856
    Lot code
    • A2825134
    • A2825153
    • A3825063

  8. Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; Soft-VU of 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches;

    UDI-DI
    • 10714001
    • 25051684007778
    • 15051684007771
    Lot code
    • A2425078
    • A3325036
    • A3525030
    • A3525031
    • A3725102

  9. Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; Soft-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;

    UDI-DI
    • 10734301
    • 25051684010112
    • 15051684010115
    Lot code
    • A2825021
    • A2825129
    • A3325027
    • A3425027
    • A3525014
    • A3825095

  10. Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; Soft-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch); Box Quantity: 5 pouches;

    UDI-DI
    • 10714017
    • 25051684007921
    • 15051684007924
    Lot code
    • A2425089

  11. Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; Soft-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;

    UDI-DI
    • 10707103
    • 25051684006177
    • 15051684006170
    Lot code
    • A3325043

  12. Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; Soft-VU of 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;

    UDI-DI
    • 10732301
    • 25051684009727
    • 15051684009720
    Lot code
    • A2825022
    • A3025035
    • A3025037

  13. Product details

    AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers;
    ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM;
    Catalog No.: 13709804;
    Product/UPN No.: H787137098045 (Box), H787137098040 (Pouch);
    Box Quantity: 5 pouches;

    UDI-DI
    • 13709804
    • 25051684006085
    • 15051684006088
    Lot code
    • A2825131

  14. Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; Soft-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;

    UDI-DI
    • 10714018
    • 25051684007938
    • 15051684007931
    Lot code
    • A2825145

  15. Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; Soft-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quantity: 5 pouches;

    UDI-DI
    • 10714024
    • 25051684007983
    • 15051684007986
    Lot code
    • A2825152
    • A3225009

  16. Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; Soft-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;

    UDI-DI
    • 10731401
    • 25051684009475
    • 15051684009478
    Lot code
    • A2825042

  17. Product details

    AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers;
    ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM;
    Catalog No.: 13709704;
    Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch);
    Box Quantity: 5 pouches;

    UDI-DI
    • 13709704
    • 25051684006030
    • 15051684006033
    Lot code
    • A3025039
    • A3225033

  18. Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; Soft-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;

    UDI-DI
    • 10710013
    • 25051684007440
    • 15051684007443
    Lot code
    • A3625012
    • A3825055

  19. Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; Soft-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;

    UDI-DI
    • 10714011
    • 25051684007877
    • 15051684007870
    Lot code
    • A3025038
    • A3025051

  20. Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; Soft-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouches;

    UDI-DI
    • 10714040
    • 25051684008102
    • 15051684008105
    Lot code
    • A2725049

Recall details

Company began the recall
Sold in

Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.

Company
Angiodynamics, Inc.Queensbury, New York
Hazard
Manufacturing problem
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
98463
Recall numbers
Z-1856-2026 to Z-1875-2026

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

Other manufacturing problem recalls

See all: Other manufacturing problem recalls

Summary by Recall Canary, written with AI · summary updated Oct 25, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)