Soft-Vu 50722631Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787507226310), received between Sep 13, 2023 and Sep 13, 2023 — 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.

• InjurySep 13, 2023Fracture; Migration; Fracture; Migration

  AN END USER REPORTED AN ISSUE WITH A SOFT-VU 90PT 6F X 100CM 038 B 10SH CATHETER. THE CATHETER INTRODUCER CHEATER ON THE END OF THE CATHETER [TIP STRAIGHTENER SLEEVE TUBING], THAT IS USED TO STRAIGHTEN THE TIP OF THE CATHETER, WAS INTRODUCED INTO THE PATIENT DURING A PULMONARY EMBOLISM CASE. THIS PIECE WENT UNNOTICED DURING THE PE CASE. THE PATIENT RETURNED TO THEIR ROOM AND WAS HAVING COMPLICATIONS. THE NEXT DAY THE PATIENT WENT FOR A CT OF THE CHEST WHERE A FOREIGN BODY WAS FOUND IN THE PULMONARY ARTERY. THE PATIENT THEN UNDERWENT A FOREIGN BODY RETRIEVAL AND THE PIECE WAS REMOVED FROM THE PATIENT. A COMPLETE ROOT CAUSE ANALYSIS WAS COMPLETED AND WE ARE ASKING THAT ANGIODYNAMICS MAKES THIS PLASTIC PIECE A DIFFERENT COLOR OTHER THAN WHITE. PERHAPS HAVING THIS PIECE A BRIGHT COLOR WILL HELP PREVENT THE OBJECT FROM BEING ENTERED INTO A SHEATH AND ULTIMATELY THE PATIENTS BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17736650 ↗

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-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-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-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-1869-2026 · Mar 3, 2026 · Open, Classified
  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);
• 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-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-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-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-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-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-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-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-1863-2026 · Mar 3, 2026 · Open, Classified
  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 Q
• 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-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.