NAMICRecalls & reported problems across all models
Navilyst Medical, Inc. · 41 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 79
- Deaths reported
- 2
- Injuries reported
- 9
- Recalls
- 0
We found 41 models of NAMIC by Navilyst Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 79 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2016 and Nov 7, 2019 — classified as 2 deaths, 9 injuries, 68 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (33 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
Most reported NAMIC problems
Device problems
- Tear, Rip or Hole in Device Packaging33
- Air Leak21
- Component Misassembled4
- Improper Flow or Infusion4
- Leak/Splash4
- Fluid/Blood Leak3
- Adverse Event Without Identified Device or Use Problem2
- Connection Problem2
Patient problems
- Not Applicable39
- No Known Impact Or Consequence To Patient30
- Air Embolism7
- Cardiac Arrest1
- Death1
- Ischemia1
- Low Blood Pressure/ Hypotension1
- No Code Available1
NAMIC models
41 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NAMIC 70055009Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass17 reports
- NAMIC 70035009Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass5 reports
- NAMIC 806010012TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR4 reports
- 3 reports
- 3 reports
- NAMIC 70030021TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR3 reports
- 2 reports
- 2 reports
- 2 reports
- 2 reports
- NAMIC 70055003Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass2 reports
- NAMIC 70095007INJECTOR AND SYRINGE, ANGIOGRAPHIC2 reports
- NAMIC 90703062CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- NAMIC 91031303CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- NAMIC 91400400Catheter, angioplasty, peripheral, transluminal2 reports
- 1 report
- 1 report
- NAMIC 80038301Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 report
- NAMIC 91051602CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- 1 report
- 1 report
- NAMIC 64000935Set, administration, intravascular1 report
- NAMIC 64038200Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 report
- 1 report
- 1 report
- 1 death1 report
- 1 death1 report
- 1 report
- 1 report
- 1 report
- NAMIC 70015013Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 report
- NAMIC 70038200Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 report
- NAMIC 70039303Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 report
- NAMIC 70055008Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 report
- NAMIC 80085007INJECTOR AND SYRINGE, ANGIOGRAPHIC1 report
- NAMIC 80641242MONITOR, LINE ISOLATION1 report
- NAMIC 88001483CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- NAMIC 90400039System, x-ray, angiographic1 report
- NAMIC 90701482MONITOR, LINE ISOLATION1 report
- NAMIC 90703050CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- NAMIC 90703122CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
Recent NAMIC adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), IN THE DISTRIBUTOR'S WAREHOUSE A HOLE/TEAR WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE PRODUCT HAD NOT BEEN PROVIDED TO A HOSPITAL AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 9289626 ↗MalfunctionSep 5, 2019Component Misassembled; Component Misassembled
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), BLUE NON-VENTED PORT PROTECTOR CAP CONNECTED TO STOPCOCK END PORT FITTING SHOULD HAVE BEEN A VENTED WHITE PORT PROTECTOR CAP. THE NON-VENTED CAP POSSIBLY COMPROMISES A STERILE PATHWAY FOR THIS DEVICE DURING THE STERILIZATION PROCESS. THIS ONE UNIT WAS FOUND DURING 100% INCOMING INSPECTION AT THE DISTRIBUTOR AND HAD NOT BEEN DISTRIBUTED TO A HOSPITAL.
Patient problems: Not Applicable
MAUDE report 8964613 ↗MalfunctionAug 16, 2019Crack; Fluid/Blood Leak
PATIENT'S A-LINE WAS NOT TRANSDUCING. THE NURSE USED PAPAVERINE, AS WELL AS FLUSHING AND REPOSITIONING WHICH DID NOT RESOLVE THE PROBLEM. WHILE INSTILLING THE PAPAVERINE INTO THE TUBING, A CRACK WAS DISCOVERED IN THE NAMIC PRESSURE MONITORING LINE TUBING AT THE CONNECTION POINT WITH THE PAPAVERINE SYRINGE AND A SMALL PUDDLE HAD FORMED ON THE SYRINGE PUMP. THE TUBING WAS CHANGED, AND THE LEAKING WAS RESOLVED. TWO DAYS LATER, A CRACK WAS FOUND IN A SECOND NAMIC PRESSURE MONITORING TUBING AT THE CONNECTION POINT WITH THE SYRINGE AND A PUDDLE FORMED ON THE SYRINGE PUMP. IN THIS CASE, A POOR TRACING WAS NOTED AND WAS RESOLVED WHEN THE TUBING WAS CHANGED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8900834 ↗InjuryAug 8, 2019Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), END USER HOSPITAL WAS UTILIZING A 60" FLEXCIL CONTRAST INJECTION LINE (WITH F-M) FITTINGS ALONG WITH AN EDWARD'S EXTENSION TUBE WHICH WAS CONNECTED TO A NAMIC STOPCOCK. "AS PREPARATION, THE FIRST AIR INSIDE INJECTOR WAS REMOVED AND THE TUBING CONNECTIONS WERE SECURELY TIGHTENED. PRIOR PROCEDURE, CONTRAST MEDIA WAS FLASHED INTO A 10ML SYRINGE OF THE OPERATOR SIDE. THEN ANGIOGRAPHY PROCEDURE BEGAN BY AN INJECTOR (5ML INJECTED, 2ML/SEC). IMMEDIATELY AIR WAS OBSERVED IN THE CATHETER ON THE IMAGE. THEREFORE, THE OPERATOR STOPPED INJECTING THE CONTRAST MEDIA IMMEDIATELY AND STOPPED THE ANGIOGRAPHY PROCEDURE." NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE USED DEVICES WERE DISCARDED AT THE HOSPITAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8875673 ↗InjuryJul 31, 2019Fracture; Fracture
AS REPORTED BY HOSPITAL IN THE (B)(6), WHILE USING AN ANGIOGRAPHIC CONVENIENCE KIT, " THE PATIENT HAS HAD CHEST PAINS / ISCHEMIA AND ST ELEVATIONS AFTER AIR HAS ENTERED THE CORONARY. PATIENT HAS RECOVERED." THE DEVICE USED IN THE REPORTED PROCEDURE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Ischemia
MAUDE report 8845237 ↗MalfunctionJul 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), WHEN UTILIZING AN ANGIOGRAPHIC CONVENIENCE KIT, " AFTER THE LINES WERE CONNECTED WITH CONTRAST AND SALINE, THE CONTROL SYRINGE WAS CONNECTED TO THE MANIFOLD. THEN, AS AIR REMOVAL WAS ATTEMPTED, A FOREIGN SUBSTANCE WS FOUND INSIDE THE SYRINGE." THERE WERE NO PATIENT COMPLICATIONS NOR INJURY. THE USED SYRINGE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8802722 ↗MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY HOSPITAL, THE SEAL (STOPPER) ON THE PLUNGER OF THE 10ML ANGIOGRAPHIC SYRINGE PACKAGED WITHIN THEIR CONVENIENCE KIT "IS NOT TIGHT AND THERE IS WIGGLE ROOM CAUSING AIR TO GET INTO THE SYSTEM AT THE BACK PORTION OF THE SYRINGE." THIS HAS BEEN OBSERVED DURING PREP. NO AIR HAS BEEN INJECTED INTO A PATIENT. NO SAMPLES HAVE BEEN RETAINED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8786346 ↗MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY HOSPITAL, THE SEAL (STOPPER) ON THE PLUNGER OF THE 10ML ANGIOGRAPHIC SYRINGE PACKAGED WITHIN THEIR CONVENIENCE KIT "IS NOT TIGHT AND THERE IS WIGGLE ROOM CAUSING AIR TO GET INTO THE SYSTEM AT THE BACK PORTION OF THE SYRINGE." THIS HAS BEEN OBSERVED DURING PREP. NO AIR HAS BEEN INJECTED INTO A PATIENT. NO SAMPLES HAVE BEEN RETAINED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8786345 ↗DeathJun 21, 2019Leak/Splash; Leak/Splash
AS REPORTED BY CATH LAB MANAGER, ONE OF THE HOSPITAL'S PHYSICIANS INJECTED AN AIR BUBBLE INTO A PATIENT ON (B)(6) 2019 DURING A CASE. AN AIR BUBBLE HAD BEEN OBSERVED IN THE SYRINGE NEAR THE PLUNGER. THE PATIENT WAS HAVING THE PROCEDURE DUE TO AN "EMERGENT STEMI CASE" AND PASSED AWAY DURING THE PROCEDURE. THE CAUSE OF DEATH AND RELATIONSHIP TO THIS EVENT (IF ANY) HAS NOT BEEN PROVIDED TO ANGIODYNAMICS YET. ANGIODYNAMICS HAS MADE MULTIPLE ATTEMPTS TO CONTACT PERSONNEL AT THE HOSPITAL, BUT THEY HAVE, AS OF YET, BEEN UNAVAILABLE. THE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE CONTINUING. THE PRODUCTS USED DURING THE PROCEDURE HAVE BEEN DISPOSED OF AT THE HOSPITAL.
Patient problems: Air Embolism; Death
MAUDE report 8723209 ↗MalfunctionJun 18, 2019Leak/Splash; Leak/Splash
AS REPORTED, END USER IS COMPLAINING ABOUT THE TOUHY-BORST VALVE ON THE Y-ADAPTOR IN THEIR CONVENIENCE KIT LETTING AIR INTO THE SYSTEM. NO AIR HAS BEEN INJECTED AND THERE HAS BEEN NO PATIENT INJURY. A USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8709444 ↗MalfunctionMay 20, 2019Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED, WITH A CONVENIENCE KIT, AIR BUBBLES WERE BELIEVED TO BE ENTERING THE LINE AT THE CONNECTION OF THE DISPOSABLE TRANSDUCER AND THE PRESSURE MONITORING LINE. "THE CONNECTIONS WERE THEN TIGHTENED, AND EVENTUALLY CHANGED OUT." NO AIR WAS INJECTED AND THERE WAS NO PATIENT INJURY. SAMPLES ARE BEING RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8623261 ↗MalfunctionMay 20, 2019Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED, WITH A CONVENIENCE KIT, AIR BUBBLES WERE BELIEVED TO BE ENTERING THE LINE AT THE CONNECTION OF THE DISPOSABLE TRANSDUCER AND THE PRESSURE MONITORING LINE. "THE CONNECTIONS WERE THEN TIGHTENED, AND EVENTUALLY CHANGED OUT." NO AIR WAS INJECTED AND THERE WAS NO PATIENT INJURY. SAMPLES ARE BEING RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8623260 ↗MalfunctionDec 7, 2018Component Misassembled; Component Misassembled
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), BLUE NON-VENTED PORT PROTECTOR CAP CONNECTED TO STOPCOCK END PORT FITTING SHOULD HAVE BEEN A VENTED WHITE PORT PROTECTOR CAP. THE NON-VENTED CAP POSSIBLY COMPROMISES A STERILE PATHWAY FOR THIS DEVICE DURING THE STERILIZATION PROCESS. THIS ONE UNIT WAS FOUND DURING 100% INCOMING INSPECTION AT THE DISTRIBUTOR AND HAD NOT BEEN DISTRIBUTED TO A HOSPITAL.
Patient problems: Not Applicable
MAUDE report 8141221 ↗MalfunctionNov 2, 2018Unsealed Device Packaging; Unsealed Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A COMPROMISED POUCH SEAL WAS FOUND ON A GUIDEWIRE INTRODUCER POUCH, THEREBY BREACHING STERILITY. THE POUCH HAD NOT BEEN PROVIDED TO A HOSPITAL AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 8032170 ↗MalfunctionNov 2, 2018Unsealed Device Packaging; Unsealed Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A COMPROMISED POUCH SEAL WAS FOUND ON A GUIDEWIRE INTRODUCER POUCH, THEREBY BREACHING STERILITY. THE POUCH HAD NOT BEEN PROVIDED TO A HOSPITAL AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 8032169 ↗
Other Navilyst Medical, Inc. products
All Navilyst Medical, Inc. devices →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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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