ARROW IPN923526Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902206739), received between Jan 31, 2023 and Jul 27, 2023 — classified as 4 malfunctions.

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

3 other recalls cover devices cleared under the same FDA submission (K892530); 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.

• MalfunctionJul 27, 2023Material Rupture; Material Rupture

  THE REPORT STATES, "WE HAD 3 5FR X 110 WEDGES ( AI- 07124 ) FAIL, THE BALLOON BROKE".

  Patient problems: Insufficient Information

  MAUDE report 17409639 ↗
• MalfunctionJul 27, 2023Material Separation; Material Separation

  THE REPROT STATES, "WE HAD 3 5FR X 110 WEDGES ( AI- 07124 ) FAIL, THE BALLOON BROKE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17409610 ↗
• MalfunctionJul 27, 2023Material Rupture; Material Rupture

  THE REPORT STATES, "WE HAD 3 5FR X 110 WEDGES ( AI- 07124 ) FAIL, THE BALLOON BROKE".

  Patient problems: Insufficient Information

  MAUDE report 17409330 ↗
• MalfunctionJan 31, 2023Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "THE CUSTOMER CONTACTED TELEFLEX BY EMAIL ADVISING THEY WERE HAVING ISSUES ADVANCING THE RECOMMENDED 0.25" J TIP WIRE WHICH WAS VERY TIGHT AT THE TIP. THE CLINICAL SPECIALIST CONTACTED THE CUSTOMER TO TROUBLE SHOOT AND SUGGESTED THEY TRY AN 0.14" WIRE WHICH WAS ALSO VERY TIGHT PASSING THROUGH THE LUMEN AT THE TIP. THE LUMEN WAS TOO TIGHT TO ADVANCE EITHER WIRE. THE PATIENT WAS A VERY COMPLEX CASE WHO HAD A VERY DIFFICULT ANATOMY, THE DEVICE WAS REMOVED. ANOTHER DEVICE FROM THE SAME LOT NUMBER WAS OPENED AND THE SAME ISSUE OCCURRED PRIOR TO BEING USED ON THE PATIENT. AS A RESULT OF THE PATIENT'S DIFFICULT ANATOMY THE PROCEDURE WAS ABANDONED. THERE WAS NO INJURY CAUSED TO THE PATIENT AS A RESULT OF EITHER TWO DEVICE FAILURES AND THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE FINE." ADDITIONAL INFORMATION STATES THAT "EVERYTHING WAS OTHERWISE NORMAL. WE WOULD NOT USE A KINKED CATHETER AND ALL CATHETERS ARE INSPECTED PRIOR TO INSERTION INTO A PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271451 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K892530. One submission often covers many models, so check the product and lot details in each record.

• Z-0716-2020 · Nov 15, 2019 · Terminated
  Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
• Z-0715-2020 · Nov 15, 2019 · Terminated
  Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
• Z-1057-2013 · Mar 4, 2013 · Terminated
  Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in ri