RHVRecalls & reported problems across all models
Abbott Vascular Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 80
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of RHV by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 80 adverse event reports in the FDA's MAUDE database, received between Apr 10, 2017 and Sep 17, 2026 — classified as 80 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (59 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported RHV problems
Device problems
- Loose or Intermittent Connection59
- Leak/Splash20
- Unstable14
- Contamination /Decontamination Problem11
- Product Quality Problem3
- Device Operates Differently Than Expected2
- Material Separation2
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions66
- No Consequences Or Impact To Patient10
- No Patient Involvement4
- No Known Impact Or Consequence To Patient1
RHV models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
Recent RHV adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Loose or Intermittent Connection
It was reported that during an unspecified procedure, when attempting to make an injection, the rotating hemostatic valve became loose from the stopcock. An unspecified device was used to complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807957 ↗MalfunctionSep 15, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771416 ↗MalfunctionSep 15, 2026Loose or Intermittent Connection
It was reported the 3-way Stopcock became disconnected from the Rotating Hemostatic Valve. There were no adverse patient effects. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771414 ↗MalfunctionAug 31, 2026Loose or Intermittent Connection
It was reported that during an unspecified procedure one Hemo Valve Rotating (RHV) device came loose from the 3-way stopcock during preparation. Another RHV was attempted to be used but came loose after being connected to a catheter. A new RHV was used to complete the procedure. There were no adverse patient effects or clinically significant delay in the procedure. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50526111 ↗MalfunctionAug 31, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525800 ↗MalfunctionJul 17, 2026Leak/Splash; Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25857234 ↗MalfunctionJul 9, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25772725 ↗MalfunctionJul 9, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25772709 ↗MalfunctionJul 9, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT DURING PREPARATION, THE THREADING OF A ROTATING HEMO VALVE (RHV) ACCESSORY WAS UNABLE TO PROPERLY ENGAGE WITH A STOPCOCK. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25772705 ↗MalfunctionJul 9, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25772694 ↗MalfunctionJul 9, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25772693 ↗MalfunctionJul 9, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25772692 ↗MalfunctionJul 9, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25772653 ↗MalfunctionJul 9, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25772648 ↗MalfunctionMar 19, 2026Loose or Intermittent Connection; Unstable
IT WAS REPORTED THE THREE-WAY STOPCOCK DID NOT FIT SECURELY INTO THE ROTATING HEMOSTATIC VALVE (RHV), AND THE CONNECTION PART REMAINED LOOSE, ROTATING FREELY. ATTEMPTS TO RECONNECT WERE UNSUCCESSFUL; THEREFORE, A NEW Y-CONNECTOR WAS USED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24642726 ↗
Other Abbott Vascular Inc. products
- MITRACLIP8 models · 5,973 reports · 2 recalls
- NC TREK56 models · 1,842 reports · 12 recalls
- Armada213 models · 1,904 reports
- Indeflator7 models · 1,196 reports · 9 recalls
- XIENCE Sierra56 models · 1,161 reports · 1 recall
- XIENCE Skypoint69 models · 1,142 reports
- Graftmaster15 models · 1,071 reports
- TREK50 models · 909 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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