Soft-Vu 10732302Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787107323020), received between Jun 20, 2017 and Jun 20, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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

Recent adverse event reports

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

• InjuryJun 20, 2017Fracture; Fracture

  AS REPORTED TO ANGIODYNAMICS ON MAY 25, 2017: THE PHYSICIAN WAS PERFORMING AN ANGIOPLASTY OF THE LEFT LEG. HE WAS GOING UP AND OVER FROM THE RIGHT GROIN. PATIENT HAD TWO EXISTING ILIAC STENTS. THE PHYSICIAN USED AN AMPLATZ WIRE BECAUSE HE WAS WORRIED ABOUT GETTING THROUGH THE TORTUOUS ANATOMY. WHEN BACKING THE SOS OMNI CATHETER OUT OF THE PATIENT, THE WIRE GOT CAUGHT ON ONE OF THE PATIENT'S STENTS. HE USED FORCE TO PULL THE WIRE BACK AFTER HE MET RESISTANCE FROM THE STENT. IMAGINING SHOWED THAT A PORTION OF THE RADIOPAQUE TIP DETACHED FROM THE PROXIMAL END OF THE CATHETER. THE PHYSICIAN WAS ABLE TO RETRIEVE ALL PIECES THROUGH THE SHEATH AND COMPLETE THE PROCEDURE WITH NO HARM TO THE PATIENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6653300 ↗

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-1859-2026 · Mar 3, 2026 · Open, Classified
  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 Quant
• 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-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-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-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-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
• 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-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-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-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-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-1871-2026 · Mar 3, 2026 · Open, Classified
  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 Quantit
• 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-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

…and 8 more.