ARROW IPN917225Recalls & reported problems
Teleflex Incorporated · Balloon Wedge Pressure Catheter · Class 2
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902180312), received between Oct 4, 2022 and Aug 11, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
Device problems
- Leak/Splash2
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT "THERE WAS NO PROBLEM DURING AN INFLATION TEST BEFORE USE. HOWEVER, WHEN THE USER INFLATED THE BALLOON SEVERAL TIMES IN THE PATIENT BODY AFTER INSERTION OF THE CATHETER, THE BALLOON GOT RUPTURED. THE USER REMOVED THE CATHETER AND FINISHED THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED. ACCORDING TO THE USER, THE BALLOON MIGHT POSSIBLY HAVE BEEN DAMAGED BY BEING CAUGHT AT THE SUTURE WHEN INSERTING THE CATHETER." THE RUPTURE OCCURRED AFTER "A FEW MINUTES". THE CATHETER WAS NOT REPLACED. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: Insufficient Information
MAUDE report 17515380 ↗MalfunctionOct 4, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE CATHETER DID NOT WORK DURING USE. THE REPORT STATE THAT IT WAS PROBABLY A DEFECTIVE VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15537680 ↗
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-0715-2020 · Nov 15, 2019 · TerminatedArrow Berman Angiographic Catheter 50cc Item Number: AI-07130
- Z-0716-2020 · Nov 15, 2019 · TerminatedArrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
- Z-1057-2013 · Mar 4, 2013 · TerminatedArrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in ri
Other CATHETER, FLOW DIRECTED devices
- Graftmaster 1012580-19Abbott Vascular Inc. · CATHETER, FLOW DIRECTED30 deaths225 reports
- SWAN-GANZ CCOMBO V 777F8Edwards Lifesciences LLC · CATHETER, FLOW DIRECTED2 recalls92 reports
- Graftmaster 1012581-16Abbott Vascular Inc. · CATHETER, FLOW DIRECTED21 deaths147 reports
- SWAN-GANZ CCOMBO V 774F75Edwards Lifesciences LLC · CATHETER, FLOW DIRECTED2 recalls2 deaths41 reports
- Graftmaster 1012581-19Abbott Vascular Inc. · CATHETER, FLOW DIRECTED12 deaths135 reports
- Graftmaster 1012582-19Abbott Vascular Inc. · CATHETER, FLOW DIRECTED13 deaths77 reports
- SWAN-GANZ VIP 831F75Edwards Lifesciences LLC · CATHETER, FLOW DIRECTED1 recall23 reports
- Graftmaster 1012580-26Abbott Vascular Inc. · CATHETER, FLOW DIRECTED13 deaths72 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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