NA 5019 (UDI 00643169300842)Recalls & reported problems
Medtronic, Inc. · SPLITTER 5019 M-4 HV NG ACI GBL 17L · Class 3 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169300842), received between Aug 31, 2018 and Aug 27, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Device Markings/Labelling Problem1
- Low impedance1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Appropriate Device Problem Term/Code Not Available
It was reported that Right Ventricular (RV) lead and adaptor exhibited a failure. The lead and adaptor remain in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50475530 ↗MalfunctionApr 8, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE USE BY DATE ON THE SPLITTER DID NOT ALIGN WITH PACKING MATERIALS. THE ISSUE WAS NOTED PRIOR TO USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9937185 ↗InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND WILL NOT BE REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 8983824 ↗MalfunctionAug 31, 2018Low impedance; Low impedance
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SPLITTER KIT HAD OUT OF NORMAL IMPEDANCE MEASUREMENTS. THE SPLITTER KIT WAS NOTED USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7838747 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.