ARROW IPN036196Recalls & reported problems
Teleflex Incorporated · Pressure Injectable Three-Lumen Hemodialysis Catheterization for High Volume Infusions · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 40801902111867), received between Apr 18, 2024 and May 14, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Apr 21, 2026Open, Classified
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-2374-2026 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Obstruction of Flow1
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.
MalfunctionMay 14, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT: "THE SURGEON ATTEMPTED TO PLACE CATHETER. ON 2ND ATTEMPT, THE RED PORT WOULD NOT ASPIRATE WELL. 3RD ATTEMPT WAS SUCCESSFUL. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE"." ASSOCIATED COMPLAINTS 9680794-2024-00446, 9680794-2024-00465 AND 9680794-2024-00443.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19307790 ↗MalfunctionApr 18, 2024
SURGEON ATTEMPTED TO PLACE HD QUINTON CATHETER. ON 2ND ATTEMPT, THE RED PORT WOULD NOT ASPIRATE WELL. 3RD ATTEMPT WAS SUCCESSFUL.
Patient problems: Insufficient Information
MAUDE report 19132833 ↗
Other CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED devices
- Power-Trialysis catheter 5605150Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls13 reports
- Power-Trialysis catheter 5605240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls8 reports
- MAHURKAR 8888101002HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls1 death8 reports
- MAHURKAR 8888102003HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- Power-Trialysis catheter 5615200Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- Power-Trialysis Slim-Cath catheter 5855240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- MAHURKAR 8888101003HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- MAHURKAR 8888102004HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.