Split Cath® III ASPC32-3E.Recalls & reported problems
Medical Components, Inc. · 14F X 32CM SPLIT CATH® III CATHETER SET (CUFF 27CM FROM TIP) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884908003895), received between Jun 20, 2018 and Apr 8, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Disconnection” (2 reports).
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.
Most reported problems
Device problems
- Disconnection2
- Break1
- Fracture1
Patient problems
- Blood Loss1
- Foreign Body In Patient1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2022Disconnection; Disconnection
WHEN DISCONNECTING THE CATHETER, AFTER TO UNSCREW THE LINE, THE VENOUS LINE HAS BEEN "SECTIONED".
Patient problems: Insufficient Information
MAUDE report 14052177 ↗MalfunctionJul 11, 2019Disconnection; Disconnection
CATHETER WAS PLACED ON (B)(6) 2019. THE WING, ALLOWING THE CATHETER TO BE HELD BY WIRES, WAS DISCONNECTED. THE WING REMAINED ATTACHED TO THE WIRES AND THE CATHETER CAME OUT. THE CATHETER WAS TORN OFF BY THE PATIENT ON (B)(6) 2019, AFTER THE CATHETER DISCONNECTED FROM THE WING.
Patient problems: Blood Loss
MAUDE report 8781790 ↗MalfunctionMay 8, 2019Fracture; Fracture
A NEW CATHETER DRESSING WAS APPLIED AND THE CATHETER WAS TESTED. AIR BUBBLES WERE PRESENT WHEN SUCTIONING THE VENOUS BRANCH. A CRACK WAS NOTED JUST BELOW THE SUTURE WINGS. PATIENT WAS HOSPITALIZED, THE SPLIT CATH WAS REMOVED AND A FEMORAL CATHETER WAS INSERTED. PATIENT IS CHRONICALLY DIALYZED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8591340 ↗MalfunctionJun 20, 2018Break; Break
DURING THE INSERTION OF THE CATHETER, IT HAS BEEN DIFFICULT TO MOUNT THE GUIDEWIRE. DUE TO AN IMPORTANT HEADACHE, WE WERE OBLIGED TO STOP THE INSERTION AND WHEN REMOVING THE GUIDEWIRE, A PART OF IT DID NOT STAY ATTACHED.
Patient problems: Foreign Body In Patient
MAUDE report 7618678 ↗
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