Soft-Vu 10733201Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787107332010), received between Jan 5, 2021 and Oct 23, 2025 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A SOFT-VU RIM 4F X 65CM 035 B 0SH. DURING A PTA CROSSOVER FROM RIGHT TO LEFT PROCEDURE, THE TIP OF THE CATHETER DETACHED INSIDE OF THE PATIENT. A COOK 180CM AMPLATZ WIRE WAS BEING USED AT THE TIME. THE TIP WAS REMOVED USING ANOTHER INSTRUMENT. THE PROCEDURE WAS THEN COMPLETED WITH A NEW OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367678 ↗
• MalfunctionFeb 17, 2021Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A SOFT-VU RIM ANGIOGRAPHIC CATHETER. THEY WERE REMOVING THE 4F RIM OVER A TERUMO GLIDE WIRE AND THE TIP RIPPED OFF (DETACHED) WHILE OUTSIDE THE PATIENT. THERE WAS NO HARM TO THE PATIENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339545 ↗
• MalfunctionJan 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AN DISTRIBUTOR'S TERRITORY MANAGER REPORTED AN ISSUE WITH A SOFTVU RIM 4FX65CM .035 ANGIOGRAPHIC CATHETER. THE END USER REPORTED A 0.035 GUIDEWIRE WAS USED TO PLACE THE SOFTVU ANGIOGRAPHIC CATHETER. THE TIP OF THE CATHETER DETACHED INSIDE OF THE PATIENT AND HAD TO BE RETRIEVED USING A SNARE. THE CATHETER WAS REPLACED WITH A NEW OF THE SAME WITH NO REPORTED ISSUES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE DEVICE WAS REPORTED AS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11117916 ↗
• MalfunctionJan 5, 2021Crack; Crack

  AN DISTRIBUTOR'S TERRITORY MANAGER REPORTED AN ISSUE WITH A SOFTVU RIM 4FX65CM .035 ANGIOGRAPHIC CATHETER. THE END USER REPORTED THAT THE SOFTVU ANGIOGRAPHIC CATHETER WAS USED IN A VERY CALCIFIED VESSEL AND THE TIP WAS NOTED TO LOOK VERY FRAGILE AND LOOSE AFTER THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE DEVICE WAS REPORTED AS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11117813 ↗

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

…and 8 more.