AccuVu 13709701Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H787137097010), received between Nov 29, 2017 and Jul 8, 2020 — classified as 1 injury, 1 malfunction.

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

21 other recalls cover devices cleared under the same FDA submission (K112452, K161596); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2020Fracture; Fracture

  ANGIODYNAMICS RECEIVED FDA MEDWATCH REFERENCE MW5094777. A RISK MANAGER REPORTED THAT THE ACCU-VU OMNI FLUSH CATHETER BROKEN IN HALF WHEN THE POWER INJECTOR WAS TRIGGERED. THE PRACTITIONER WAS ABLE TO SAFELY RETRIEVE THE CATHETER FROM THE FEMORAL ARTERY. NO END USER IDENTIFYING INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10247242 ↗
• MalfunctionNov 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: DURING PREP FOR AN ANGIOGRAPHIC PROCEDURE, IT WAS REPORTED THE TIP OF THE ANGIOGRAPHIC CATHETER DETACHED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7068046 ↗

Recalls under the same FDA submission

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

• 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-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-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-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-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-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-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-1866-2026 · Mar 3, 2026 · Open, Classified
  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 Quanti
• 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-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-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-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-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-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 6 more.