AccuVu 13709703Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787137097030), received between Apr 28, 2016 and Mar 21, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH AN AV 5 100 035 OF 1CM 21RO SIZING CATHETER. DURING THE PROCEDURE, THE MARKER FELL OFF, INTO THE PATIENT. THE DECISION WAS MADE TO LEAVE THE MARKER IN SITU. THE PROCEDURE WAS COMPLETED WITH THIS CATHETER. THE TREATING PHYSICIAN ATTRIBUTED THE MARKERBAND DETACHMENT POSSIBLY TO ITS USE WITH THE COOK RUPS SET. DURING THE PROCEDURE, THE CATHETER IS WITHDRAWN THROUGH THE METAL CANNULA SEVERAL TIMES DURING A CASE AND IN DOING SO, IT MAY HAVE CAUSED THE MARKERBAND TO DETACH. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13840066 ↗
• InjurySep 20, 2017Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON SEPTEMBER 01, 2017: DURING A TIPSS PROCEDURE, THE CATHETER TIP BROKE OFF INSIDE OF THE PATIENT. THE FRAGMENT WAS SUCCESSFULLY REMOVED VIA A SNARE. THE DEVICE WAS REMOVED AND SET ASIDE. THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT SUFFER ANY HARM OR INJURY DUE TO THIS EVENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6878973 ↗
• MalfunctionSep 20, 2017Fracture; Fracture

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017 VIA A (B)(4); THE OMNI FLUSH CATHETER WAS PLACED OVER A GLIDE WIRE. THE GLIDE WIRE WAS REMOVED FOR INJECTION OF CONTRAST VIA POWER INJECTOR FOR VISUALIZATION. THE INJECTION WAS NOT COMPLETE AFTER THREE ATTEMPTS. THE OMNI FLUSH CATHETER FOUND WITH A TEAR/ LARGE HOLE IN CATHETER, THUS MAKING IT UNABLE TO DELIVER THE CONTRACT TO THE END OF THE CATHETER. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6878968 ↗
• MalfunctionApr 28, 2016Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED APRIL 05, 2016, A (B)(6), FEMALE PATIENT PRESENTED FOR AN ANGIOGRAPHIC PROCEDURE FOR A FILTER REMOVAL. DURING THE CASE, UPON THREADING THE CATHETER OVER THE WIRE, THE PHYSICIAN NOTED THE CATHETER TO BE SPLIT. THE CATHETER WAS REMOVED FROM THE WIRE WITH NO REPORTED COMPLICATIONS. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5615760 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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),

…and 6 more.