RHV 23242Recalls & reported problems
Abbott Vascular Inc. · Rotating Hemostatic Valve .096" · Class 2
Quick summary
This Abbott Vascular rotating hemostatic valve is a small stopcock-style accessory used to control bleeding flow during cardiopulmonary bypass procedures. The 62 reports mostly describe the valve coming loose or not threading properly onto the stopcock or catheter, sometimes leaking, plus some contamination concerns. No deaths and no injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 66
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 08717648013362), received between Aug 1, 2017 and Sep 17, 2026 — classified as 66 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (56 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.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection56
- Leak/Splash12
- Contamination /Decontamination Problem11
- Unstable11
- Improper or Incorrect Procedure or Method1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 66 reports, 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 ↗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 24642630 ↗MalfunctionFeb 16, 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 INTERFACE CONTINUED TO ROTATE LOOSELY. 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 24349238 ↗MalfunctionFeb 16, 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 ROTATING HEMOSTATIC VALVE 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 24349207 ↗MalfunctionJan 19, 2026Loose or Intermittent Connection; Unstable
IT WAS REPORTED THAT A THREE-WAY STOPCOCK DID NOT FIT SECURELY INTO THE Y-CONNECTOR OF THE ROTATING HEMOSTATIC VALVE (RHV) AND THE CONNECTION WAS LOOSE AND ROTATING FREELY. ATTEMPTS TO RECONNECT WERE UNSUCCESSFUL; THEREFORE, A NEW RHV 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 24111337 ↗MalfunctionJan 15, 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 24078614 ↗MalfunctionJan 15, 2026Loose or Intermittent Connection; Unstable
SUBSEQUENTLY AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, IT WAS NOTED THAT THE ROTATOR OF THE THREE-WAY STOPCOCK WAS ROTATING FREELY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24078560 ↗MalfunctionJan 14, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT THE THREE-WAY STOPCOCK DEVICE DID NOT FIT SECURELY INTO THE COPILOT DEVICE AND THE CONNECTION REMAINED LOOSE, ROTATING FREELY. ATTEMPTS TO RECONNECT WERE UNSUCCESSFUL SO A NEW COPILOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24071143 ↗MalfunctionJan 13, 2026Loose or Intermittent Connection; Unstable
SUBSEQUENTLY AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, IT WAS NOTED THAT THE ROTATOR OF THE THREE-WAY STOPCOCK WAS ROTATING FREELY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052327 ↗MalfunctionJan 13, 2026Loose or Intermittent Connection; Unstable
SUBSEQUENTLY AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, IT WAS NOTED THAT THE ROTATOR OF THE THREE-WAY STOPCOCK WAS ROTATING FREELY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052243 ↗MalfunctionJan 12, 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 24039035 ↗
Other Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices
- Indeflator 1003327Abbott Vascular Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass2 recalls722 reports
- Copilot 1003331Abbott Vascular Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass189 reports
- DLP® 11001GMedtronic, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass2 recalls0 reports
- DLP® 14000Medtronic, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall2 reports
- PhD™ 00884450746745Merit Medical Systems, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall2 reports
- PhD™ 00884450746714Merit Medical Systems, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall1 report
- NAMIC 64038301Medline Industries, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall1 report
- 10Fore™ Initial ReleaseMerit Medical Systems, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.