Soft-Vu 10732301Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI H787107323010), received between Jun 30, 2016 and Jul 9, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

22 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.

Recalls naming this device

1. Mar 3, 2026Open, Classified

   The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

   Z-1870-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Fracture; Fracture

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A SOFT-VU OF 4F X 65CM 035 NB 6SH. THEY PUT THE OMNI FLUSH CATHETER OVER A .035 BENTSON WIRE WITH NO ISSUES INTO THE ABDOMINAL AORTA AND POWER INJECTED AN AORTOGRAM. THEY THEN USED A .035 STANDARD ANGLED GLIDE WIRE TO GO OVER THE AORTIC BIFURCATION INTO THE SFA. THERE WAS A NORMAL AORTIC BIFURCATION, NO STENTS, STENOSIS OR IRREGULARITY SEEN IN THE ILIAC SYSTEMS. A LOWER EXTREMITY RUNOFF WAS PERFORMED THROUGH THE OMNI FLUSH AND IDENTIFIED SFA AND POP DISEASE. AT THIS POINT A .035 ABBOTT SUPRACORE WAS PASSED THROUGH THE CATHETER INTO THE SFA AND THE CATHETER WAS PULLED BACK, WHEN THE TIP OF THE CATHETER REACHED THE AORTIC BIFURCATION THERE WAS SOME RESISTANCE. THEY PUSHED THE CATHETER SLIGHTLY FORWARD AGAIN AND IT WENT EASILY, BEGAN TO WITHDRAW AGAIN AND THE TIP OF THE CATHETER SEPARATED ON THE WIRE FROM THE REST OF THE CATHETER. THEY PULLED THE CATHETER OFF AND PLACED A 6FR 45CM TERUMO DESTINATION OVER THE WIRE AND TELESCOPED THE SHEATH OFF THE DILATOR WHEN THEY REACHED THE BROKEN TIP AND THE TIP WENT INTO THE SHEATH STILL OVER THE WIRE. THEY DISCONNECTED THE SHEATH HUB AND SLOWLY PULLED THE WIRE BACK UNTIL THE

  Patient problems: Infiltration into Tissue; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461858 ↗
• MalfunctionMar 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ANGIOGRAPHIC PROCEDURE USING A SOFTVU ANGIOGRAPHIC CATHETER. PRIOR TO INSERTION, THE TREATING PHYSICIAN WAS LOADING THE CATHETER ONTO THE GUIDEWIRE WHEN THE TIP OF THE CATHETER DETACHED. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE 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 Consequences Or Impact To Patient

  MAUDE report 9805810 ↗
• InjuryMar 1, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018, ON THE (B)(6)2018, THE SURGEON WAS PERFORMING AN ANGIOGRAPHIC PROCEDURE WITH A SOFT-VU OMNI FLUSH WHEN AN INCIDENT OCCURRED WITH THE CATHETER IN-VIVO. THE SURGEON REPORTED: "OMNI FLUSH CATHETER OVER SUPRACORE WIRE, UP & OVER AORTIC BIFURCATION. ON RETRIEVING CATHETER OVER THE WIRE, WAS STUCK & BROKE => ONE PIECE BEING THE HUB, THEN THE SHAFT, AND LEAVING THE SHEPARD'S HOOK' IN THE PATIENTS SUPERIOR FEMORAL ARTERY" . THE CATHETER TIP, "SHEPARD'S HOOK" IS EMBEDDED IN THE PLAQUE, LOCATED IN THE PATIENT'S SUPERIOR FEMORAL ARTERY. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7305634 ↗
• MalfunctionFeb 7, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON JANUARY 16, 2018: A FLUSH CATHETER WAS PLACED INSIDE PATIENT. THE CATHETER HUB WAS CONNECTED TO THE POWER INJECTOR. UPON INJECTION, IT WAS NOTED THERE WAS AIR IN THE CATHETER. THIS WAS NOTED VIA FLOURO. THE INJECTOR WAS UNABLE TO GET ANY FLUID THROUGH THE TIP PF THE CATHETER AND SMALL BUBBLES WERE NOTED. THE INJECTION WAS IMMEDIATELY CEASED BEFORE THE AIR COULD ENTER THE PATIENT. A VISIBLE WEAK SPOT WAS NOTICED OUTSIDE OF THE PATIENT ON CATHETER. THE CATHETER WAS DISCONNECTED FROM INJECTOR AND IT BROKE OFF (CATHETER FRACTURED). IT WAS REPORTED THE FRACTURE WAS CLOSE TO THE CATHETER HUB. IT WAS REPORTED THE PATIENT SUFFERED NO HARM OR INJURY DUE TO THIS EVENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7247646 ↗
• MalfunctionMar 7, 2017Break; Fracture; Device Damaged Prior to Use; Break; Fracture; Device Damaged Prior to Use

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: WHEN OPENING THE STERILE PACKAGING DURING PREP FOR AN ANGIOGRAPHIC PROCEDURE IT WAS NOTED THE TIP OF THE ANGIOGRAPHIC CATHETER HAD FRACTURED OFF INSIDE OF THE PACKAGING. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6384549 ↗
• MalfunctionJun 30, 2016Device Damaged Prior to Use; Device Damaged Prior to Use

  AS REPORTED JUNE 09, 2016, A PATIENT PRESENTED OF UNKNOWN AGE AND GENDER FOR AN ANGIOGRAPHIC PROCEDURE. AT THE START OF THE PROCEDURE, WHEN THE GUIDEWIRE WAS FED THROUGH THE CATHETER, THE RADIOPAQUE PART OF THE CATHETER FRACTURED OFF. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE 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 NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5762322 ↗

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

…and 7 more.