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Soft-Vu 10707101Recalls & reported problems

Angiodynamics, Inc. · Soft-Vu Angiographic Catheter, Pigtail, Non-Braided · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787107071010), received between Nov 26, 2019 and Nov 26, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

23 other recalls cover devices cleared under the same FDA submission (K112452, K161596, K173762); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    AS REPORTED: TWO SOFT VU PIGTAIL CATHETER TIPS BROKE OFF WHILE PREPPING AND STRAIGHTENING THE TIP. NO WIRE WAS INSERTED. CATHETER NEVER LEFT THE STERILE FIELD AND WAS NOT USED ON THE PATIENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICES HAVE BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9375999 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112452, K161596, K173762. One submission often covers many models, so check the product and lot details in each record.

  • Z-1872-2026 · Mar 3, 2026 · Open, Classified
    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), H
  • Z-1870-2026 · Mar 3, 2026 · Open, Classified
    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 Qua
  • Z-1862-2026 · Mar 3, 2026 · Open, Classified
    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 Quantit
  • Z-1874-2026 · Mar 3, 2026 · Open, Classified
    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),
  • Z-1861-2026 · Mar 3, 2026 · Open, Classified
    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 Qua
  • Z-1856-2026 · Mar 3, 2026 · Open, Classified
    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 Quan
  • Z-1868-2026 · Mar 3, 2026 · Open, Classified
    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); B
  • Z-1875-2026 · Mar 3, 2026 · Open, Classified
    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), H
  • Z-1864-2026 · Mar 3, 2026 · Open, Classified
    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 Qu
  • Z-1857-2026 · Mar 3, 2026 · Open, Classified
    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 Quanti
  • Z-1860-2026 · Mar 3, 2026 · Open, Classified
    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 Qu
  • Z-1865-2026 · Mar 3, 2026 · Open, Classified
    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 Qu
  • Z-1858-2026 · Mar 3, 2026 · Open, Classified
    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 Qua
  • Z-1867-2026 · Mar 3, 2026 · Open, Classified
    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 (Po
  • Z-1873-2026 · Mar 3, 2026 · Open, Classified
    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.: H78

…and 8 more.

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Sources and updates

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