Soft-Vu 10723502Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787107235020), received between Jan 11, 2019 and Apr 1, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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

• MalfunctionApr 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN ISSUE WITH A SV BEREN 4FX65CM .035 B ANGIOGRAPHIC CATHETER. DURING AN ANGIOGRAM PROCEDURE, THE CATHETER TIP BROKE OFF WHILE THE DEVICE WAS BEING WITHDRAWN FROM THE PATIENT. THE TIP FRAGMENT WAS REMOVED VIA SNARE AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13977453 ↗
• InjuryAug 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: THIS WAS A PERIPHERAL CASE, SO THE PHYSICIAN WENT UP AND OVER DOWN THE OPPOSITE LEG WITH THE BERENSTEIN CATHETER. A .014 WIRE WAS IN PLACE AND WHEN HE WENT TO REMOVE THE CATHETER THIS IS WHEN THE {CATHETER} TIP BROKE OFF. THE PHYSICIAN THOUGHT THE TIP BROKE IN THE SFA. THE WIRE WAS STILL IN PLACE AND THE TIP WAS STILL ON THE WIRE. A BALLOON WAS DEPLOYED PAST THE BROKEN TIP OVER THE WIRE, AND THEN THE WIRE/BALLOON PULLED BACK TO WHERE THE TIP WAS ABLE TO BE REMOVED COMPLETELY FROM THE PATIENT. NO INJURY WAS CAUSED, THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS FINE. THERE WAS NO PERMANENT HARM OR INJURY TO THE PATIENT, AND THE PATIENT WAS REPORTED AS STABLE POST PROCEDURE. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8893020 ↗
• InjuryApr 2, 2019Fracture; Fracture

  DURING AN ANGIOGRAPHIC PROCEDURE, IT WAS REPORTED THE SOFT-VU ANGIOGRAPHIC CATHETER FRACTURED INSIDE OF THE PATIENT. THE TREATING PHYSICIAN SUCCESSFULLY RETRIEVED THE FRACTURE PIECE. THE PATIENT SUFFERED NO ADVERSE EFFECT 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 8474755 ↗
• MalfunctionJan 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NURSING UNIT MANAGER (OPERATING THEATRES) FROM A HOSPITAL IN (B)(6) ADVISED ANGIODYNAMICS' DISTRIBUTOR THAT THEY HAD 1 CATHETER WHICH FELL APART BEFORE IT WAS USED. WHEN THE CATHETER WAS OPENED AND PRIOR TO IT BEING USED, THE DEFECT WAS DISCOVERED AND NOT USED ON THE PATIENT. THE BLACK TIP AT THE END OF THE CATHETER (RADIO OPAQUE BIT) CAME OFF AS THE CATHETER WAS BEING PREPPED FOR USE. THERE WAS NO PATIENT HARM OR INJURY DUE TO THIS EVENT. 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 8239801 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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

…and 8 more.