ARROW IPN001180Recalls & reported problems
Teleflex Incorporated · Arrow-Clark(TM) VectorFlow(TM) Retrograde Hemodialysis Catheterization Set Long-Term Access. Catheter Length, Tip to Cuff: 42 cm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902112887), received between Nov 15, 2024 and Nov 15, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K141051); 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.
Reports received per month
Most reported problems
Device problems
- Connection Problem1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2024Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem
IT WAS REPORTED, "WHEN THE USER FLUSHED EACH LUMEN AFTER INSERTION OF THE CATHETER, LEAK WAS FOUND FROM THE CONNECTING PART BETWEEN THE HUB ASSEMBLY AND THE CATHETER BODY. THE USER CONFIRMED THAT THE CATHETER AND THE HUB WERE CONNECTED FIRMLY AND FLUSHED, BUT LEAK OCCURRED AGAIN. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW KIT TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20696313 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K141051. One submission often covers many models, so check the product and lot details in each record.
- Z-2157-2026 · Apr 10, 2026 · Open, ClassifiedArrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272
Other Catheter, hemodialysis, implanted devices
- Palindrome 8888145014Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall312 reports
- Palindrome 8888145015Mozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death219 reports
- HemoStar Long-Term Hemodialysis Catheter 5833690Bard Access Systems, Inc. · Catheter, hemodialysis, implanted2 deaths290 reports
- Palindrome 8888119369PMozarc Medical US LLC · Catheter, hemodialysis, implanted3 recalls1 death14 reports
- HemoStar Long-Term Hemodialysis Catheter 5833730Bard Access Systems, Inc. · Catheter, hemodialysis, implanted1 death141 reports
- GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5393230Bard Access Systems, Inc. · Catheter, hemodialysis, implanted5 deaths138 reports
- Palindrome 8888119364PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 reports
- Palindrome 8888123404PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page