ARROW IPN000070Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801902002853), received between Oct 22, 2019 and Sep 16, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED " WEDGE CATHETER WOULD NOT FLUSH OR GIVE HEMODYNAMIC READING. CATHETER FLUSHED BEFORE ENTERING THE BODY. TOOK BACK OUT OF THE BODY AND IT WOULD NOT FLUSH". NO ADDITIONAL INFORMAION FROM THE CUSTOMER HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 23063824 ↗
• MalfunctionAug 8, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "WE USED 3 EACH ARROW 5F BWP CATHETERS ON A PATIENT TODAY BECAUSE TWO OFTHEM DREW BACK AIR WHEN THE DR TRIED TO PULL BACK BLOOD; ONE APPEARS TO HAVE A HOLE IN IT AND THE OTHER A CRACK---ON THE HUBS? THERE WAS NO DIFFICULTY CONNECTING IT TO THE CATHETER NOR DISCONNECTING IT FROM THE CATHETER". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN". PLEASE SEE ASSOCIATED MDR #: 3010532612-2025-00720, 3010532612-2025-00735.

  Patient problems: Insufficient Information

  MAUDE report 22749666 ↗
• MalfunctionAug 8, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "WE USED 3 EACH ARROW 5F BWP CATHETERS ON A PATIENT TODAY BECAUSE TWO OFTHEM DREW BACK AIR WHEN THE DR TRIED TO PULL BACK BLOOD; ONE APPEARS TO HAVE A HOLE IN IT AND THE OTHER A CRACK---ON THE HUBS? THERE WAS NO DIFFICULTY CONNECTING IT TO THE CATHETER NOR DISCONNECTING IT FROM THE CATHETER". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN". PLEASE SEE ASSOCIATED MDR #: 3010532612-2025-00720, 3010532612-2025-00736.

  Patient problems: Insufficient Information

  MAUDE report 22749656 ↗
• MalfunctionAug 7, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED "WE USED 3 EACH ARROW 5F BWP CATHETERS ON A PATIENT TODAY BECAUSE TWO OFTHEM DREW BACK AIR WHEN THE DR TRIED TO PULL BACK BLOOD; ONE APPEARS TO HAVE A HOLE IN IT AND THE OTHER A CRACK---ON THE HUBS? THERE WAS NO DIFFICULTY CONNECTING IT TO THE CATHETER NOR DISCONNECTING IT FROM THE CATHETER". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739175 ↗
• MalfunctionApr 24, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND DELIVERY FAIL. SO, THE MD OPEND UP THE NEW KIT TO FINISH THE PROCEDURE." NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900056 ↗
• MalfunctionFeb 9, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND THE BALLOON COULD NOT PASS FOLLOWING THE WIRE. SO THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." SAME SITE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CURRENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681729 ↗
• InjuryJan 2, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT "DURING THE RIGHT HEART CATHETERIZATION PORTION OF THE CARDIO MEMS IMPLANT PROCEDURE, PRIOR TO ANY CARDIOMEMS EQUIPMENT BEING OPENED OR USED, THE PATIENT HAD A BRADYCARDIAC ARREST. THIS HAPPENED WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE ARROW BALLOON WEDGE PRESSURE CATHETER FROM THE RIGHT ATRIUM TO THE RIGHT VENTRICLE. CARDIOMEMS IMPLANTATION WAS ABORTED. THE PATIENT RECEIVED ATROPINE AND COMPRESSIONS, AND WAS EXTERNALLY PACED FOLLOWING THE EVENT. IT WAS NOTED THE PATIENT HAS A BASELINE RIGHT BUNDLE BRANCH BLOCK. PATIENT IS STABLE AND DISCHARGED".

  Patient problems: Bradycardia; Cardiac Arrest

  MAUDE report 18427026 ↗
• MalfunctionOct 28, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TESTING ON THE TABLE, THE STAFF NOTED THAT THE BALLOON WAS NOT INFLATING INITIALLY THEN INFLATED WITH DIFFICULTY. WHEN THE CATHETER WAS INSERTED INTO THE PATIENT THE BALLOON STOPPED INFLATING. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10750282 ↗
• InjuryOct 22, 2019Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DOCTOR HAD DIFFICULTY DEFLATING THE BALLOON AFTER INSERTION. THE DOCTOR STATED THAT THE BALLOON WAS PRETESTED BEFORE INSERTION. UNDER FLUOROSCOPY, IT WAS NOTED THAT THE BALLOON DID NOT DEFLATE. THE DOCTOR TRIED DIFFERENT SYRINGES TO DEFLATE THE BALLOON, BUT NO CHANGE. AS A RESULT, THE CATHETER AND SHEATH WERE REMOVED AT THE SAME TIME, AND AFTER REMOVAL WAS NOTED THAT THE BALLOON TIP WAS MISSING. IT WAS REPORTED THAT THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9218364 ↗

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