BioFloRecalls & reported problems across all models
Navilyst Medical, Inc. · 87 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 520
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls
- 0
We found 87 models of BioFlo by Navilyst Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 520 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2016 and Jul 1, 2026 — classified as 51 injuries, 469 malfunctions.
The most frequently reported specific device problem is “Crack” (169 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 BioFlo problems
Device problems
- Crack169
- Fracture126
- Fluid/Blood Leak89
- Detachment of Device or Device Component49
- Material Puncture/Hole30
- Adverse Event Without Identified Device or Use Problem13
- Difficult to Remove11
- Infusion or Flow Problem11
Patient problems
- No Clinical Signs, Symptoms or Conditions217
- No Known Impact Or Consequence To Patient213
- Device Embedded In Tissue or Plaque27
- No Consequences Or Impact To Patient13
- Unspecified Infection11
- Foreign Body In Patient7
- Hemorrhage/Blood Loss/Bleeding6
- Pain6
BioFlo models
87 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BioFlo 45891Catheter,intravascular,therapeutic,long-term greater than 30 days58 reports
- BioFlo 02-804Catheter, hemodialysis, implanted37 reports
- BioFlo 45812Catheter,intravascular,therapeutic,long-term greater than 30 days31 reports
- BioFlo 02-803Catheter, hemodialysis, implanted30 reports
- BioFlo 45832Catheter,intravascular,therapeutic,long-term greater than 30 days24 reports
- BioFlo 75019Catheter,intravascular,therapeutic,long-term greater than 30 days23 reports
- BioFlo 45811Catheter,intravascular,therapeutic,long-term greater than 30 days21 reports
- BioFlo 45831Catheter,intravascular,therapeutic,long-term greater than 30 days17 reports
- BioFlo 45883Catheter,intravascular,therapeutic,long-term greater than 30 days13 reports
- BioFlo 45889Catheter,intravascular,therapeutic,long-term greater than 30 days13 reports
- BioFlo 03-803Catheter, hemodialysis, implanted11 reports
- BioFlo 45881Catheter,intravascular,therapeutic,long-term greater than 30 days11 reports
- BioFlo 45887Catheter,intravascular,therapeutic,long-term greater than 30 days11 reports
- BioFlo 60M140606Catheter,intravascular,therapeutic,long-term greater than 30 days11 reports
- BioFlo 75014Catheter,intravascular,therapeutic,long-term greater than 30 days11 reports
- BioFlo 03-818Catheter, hemodialysis, implanted10 reports
- BioFlo 75033Catheter,intravascular,therapeutic,long-term greater than 30 days9 reports
- BioFlo 75017Catheter,intravascular,therapeutic,long-term greater than 30 days8 reports
- BioFlo 02-819Catheter, hemodialysis, implanted7 reports
- BioFlo 03-804Catheter, hemodialysis, implanted7 reports
- BioFlo 44014PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR7 reports
- BioFlo 45802Catheter,intravascular,therapeutic,long-term greater than 30 days7 reports
- BioFlo 46470Catheter,intravascular,therapeutic,short-term less than 30 days7 reports
- BioFlo 75038Catheter,intravascular,therapeutic,long-term greater than 30 days7 reports
- BioFlo 03-819Catheter, hemodialysis, implanted6 reports
- BioFlo 45870Catheter,intravascular,therapeutic,long-term greater than 30 days6 reports
- BioFlo 45894Catheter,intravascular,therapeutic,long-term greater than 30 days6 reports
- BioFlo 45895Catheter,intravascular,therapeutic,long-term greater than 30 days6 reports
- BioFlo 46490Catheter,intravascular,therapeutic,short-term less than 30 days5 reports
- BioFlo 75-063Catheter, intravascular, therapeutic, long-term greater than 30 days5 reports
- BioFlo 45871Catheter,intravascular,therapeutic,long-term greater than 30 days4 reports
- BioFlo 60M701102Catheter,intravascular,therapeutic,long-term greater than 30 days4 reports
- BioFlo 75035Catheter,intravascular,therapeutic,long-term greater than 30 days4 reports
- BioFlo 02-805Catheter, hemodialysis, implanted3 reports
- BioFlo 44022PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
- BioFlo 44025PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
- BioFlo 45833Catheter,intravascular,therapeutic,long-term greater than 30 days3 reports
- BioFlo 45872Catheter,intravascular,therapeutic,long-term greater than 30 days3 reports
- BioFlo 45882Catheter,intravascular,therapeutic,long-term greater than 30 days3 reports
- BioFlo 45885Catheter,intravascular,therapeutic,long-term greater than 30 days3 reports
- BioFlo 60M700936Catheter,intravascular,therapeutic,long-term greater than 30 days3 reports
- BioFlo 60M780126Catheter,intravascular,therapeutic,long-term greater than 30 days3 reports
- BioFlo 75016Catheter,intravascular,therapeutic,long-term greater than 30 days3 reports
- BioFlo 02-808Catheter, hemodialysis, implanted2 reports
- BioFlo 02-820Catheter, hemodialysis, implanted2 reports
- BioFlo 02-904Catheter, hemodialysis, implanted2 reports
- BioFlo 45876Catheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- BioFlo 45888Catheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- BioFlo 46012Catheter,intravascular,therapeutic,short-term less than 30 days2 reports
- BioFlo 60M022474Catheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- BioFlo 75012Catheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- BioFlo 75024Catheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- BioFlo 03-808Catheter, hemodialysis, implanted1 report
- BioFlo 44012PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- BioFlo 44015PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- BioFlo 44017PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- BioFlo 45813Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 45837Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 45842Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 45875Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 45884Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 45892Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 45893Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 45963Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 45968Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 46016Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- BioFlo 46-023Midline catheter1 report
- BioFlo 46-027Catheter, intravascular, therapeutic, long-term greater than 30 days1 report
- BioFlo 46-029Midline catheter1 report
- BioFlo 46480Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- BioFlo 46610Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- BioFlo 60M010433Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 60M072131Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 60M1303115Catheter, intravascular, therapeutic, long-term greater than 30 days1 report
- BioFlo 60M137906Catheter, intravascular, therapeutic, long-term greater than 30 days1 report
- BioFlo 60M183481Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 60M183482Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 60M220444Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 60M61072182Catheter, intravascular, therapeutic, long-term greater than 30 days1 report
- BioFlo 60M701101Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 60M701994Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 75015Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 75031Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 75036Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 75041Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- BioFlo 75-050Catheter, intravascular, therapeutic, long-term greater than 30 days1 report
- BioFlo 75-061Catheter, intravascular, therapeutic, long-term greater than 30 days1 report
Recent BioFlo adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2026Fluid/Blood Leak; Material Puncture/Hole
A NEW ZEALAND DISTRIBUTOR REPORTED AN ISSUE WITH BIO-FLO 4F SL-55CM CATHETER KIT VALVED PG. IT WAS REPORTED THAT DURING CLINICAL USE, FLUID LEAKAGE WAS OBSERVED FROM THE EXTERNAL PORTION OF THE CATHETER TUBING. UPON CLOSER INSPECTION, A PINHOLE WAS DISCOVERED IN THE TUBING NEAR THE SECURACATH STABILIZATION DEVICE. DUE TO THE LOSS OF LINE INTEGRITY, THE DEVICE WAS REMOVED EARLIER THAN THE SCHEDULED TREATMENT PLAN REQUIRED. THERE WAS NO REPORTED PATIENT INJURY OR HARM ASSOCIATED WITH THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25678442 ↗MalfunctionJun 18, 2026Detachment of Device or Device Component
AN AUSTRALIA DISTRIBUTOR REPORTED AN ISSUE WITH BIOFLO PICC (NON-VALVED) 6FTL-55CM MST-70 KIT WITH NITINOL GUIDEWIRE PG. IT WAS REPORTED THAT AN END-USER EXPERIENCED A HUB-CATHETER SEPARATION DURING A CT TEST FLUSH WITH SALINE AT 3 ML/SEC, BELOW THE DEVICE'S RATED FLOW. THE INJECTOR ALARMED FOR HIGH PRESSURE, FOLLOWED BY A "POP," AND THE PURPLE HUB WAS OBSERVED TO HAVE SEPARATED FROM THE CATHETER. THE LINE WAS IMMEDIATELY SECURED, AND THE PATIENT REMAINED STABLE WITH NO SIGNS OF HARM. THE PICC WAS SUBSEQUENTLY REMOVED. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, OR HARM AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25547950 ↗MalfunctionMay 28, 2026Difficult to Flush; Deformation Due to Compressive Stress
A CANADA DISTRIBUTOR REPORTED AN ISSUE WITH A 5F DL BIOFLO PASV PICC. IT WAS REPORTED THAT A PATIENT EXPERIENCED DISCOMFORT WHEN FLUSHING THE GREY LUMEN PLACED IN THE UPPER ARM, WITH POSITIONAL FLOW NOTED. EVALUATION BY THE IV TEAM FOUND NO MECHANICAL OCCLUSION OR KINKING, INCLUDING REVIEW OF A PRIOR CHEST X-RAY. DURING SIMULTANEOUS FLUSHING OF BOTH LUMENS, BULGING WAS OBSERVED APPROXIMATELY 1 CM FROM THE INSERTION SITE. THE PICC WAS REMOVED AND REPLACED, RESULTING IN ADDITIONAL INTERVENTION AND DELAY IN TREATMENT.
Patient problems: Discomfort
MAUDE report 25323575 ↗MalfunctionMay 19, 2026Device Dislodged or Dislocated
A UK DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-FLO 4F SL 55CM MST-70 KIT VALVED PG. IT WAS REPORTED THAT THE PICC COILED IN THE RIGHT INTERNAL JUGULAR VEIN. THE PATIENT HAD TO UNDERGO PERIPHERAL IV CANNULATION AND THEIR LAST IV TREATMENT WAS ADMINISTERED VIA A PERIPHERAL IV CANNULA INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216315 ↗MalfunctionMay 18, 2026Device Dislodged or Dislocated
A UK DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-FLO 4F SL 55CM MST-70 KIT VALVED PG. IT WAS REPORTED THAT THE PICC COILED IN THE RIGHT SUBCLAVIAN VEIN. THE PATIENT HAD TO HAVE NEW PICC INSERTED AND PREVIOUS PICC REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25211762 ↗MalfunctionMay 18, 2026Device Dislodged or Dislocated
A UK DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-FLO 4F SL 55CM MST-70 KIT VALVED PG. IT WAS REPORTED THAT THE PICC COILED AND KINKED IN THE PATIENT'S ARM. THE PICC LINE HAD TO BE REMOVED AND A NEW PICC HAD TO BE INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25211761 ↗MalfunctionMay 15, 2026Crack
AN END USER REPORTED AN ISSUE WHEN USING THE BIOFLO 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE PG. THE HUB WAS OBSERVED TO BE CRACKED ALONG THE LUER THREADS. TREATMENT WAS DELAYED AND THE AFFECTED DEVICE HAD TO BE REMOVED AND REPLACED WITH A DIFFERENT PRODUCT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25191984 ↗MalfunctionMay 6, 2026Crack
AN END USER REPORTED AN ISSUE WITH A BIOFLO PICC (VALVED) 4F SL 55CM IR-145 KIT WITH NITINOL GW PG WHEN ATTACHING A SYRINGE FOR FLUSHING. A CRACK WAS OBSERVED AT THE HUB PRIOR TO FLUSHING, AND NO FLUSHING WAS PERFORMED. THE AFFECTED DEVICE HAD TO BE REMOVED AND REPLACED WITH A DIFFERENT PRODUCT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25104867 ↗MalfunctionApr 29, 2026Crack
AN END USER REPORTED AN ISSUE WHEN USING THE BIOFLO PICC (NON-VALVED) 6FTL-55CM MST-70 KIT PG. THE GRAY HUB WAS OBSERVED TO BE LEAKING AND WAS FOUND TO BE CRACKED ALONG THE LUER THREADS. THE AFFECTED DEVICE HAD TO BE REMOVED AND REPLACED WITH A DIFFERENT PRODUCT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25032884 ↗MalfunctionApr 21, 2026Crack
AN END USER REPORTED AN ISSUE WHEN USING THE BIOFLO 5F DL-55CM, MST-70 KIT, NON-VALVED PG. THE GRAY HUB WAS OBSERVED TO BE CRACKED ALONG THE LUER THREADS. THE AFFECTED DEVICE HAD TO BE REMOVED AND REPLACED WITH A DIFFERENT PRODUCT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948539 ↗MalfunctionMar 4, 2026Infusion or Flow Problem
A SPECTRUM DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIOFLO 5F DL-55CM MST-70 KIT NON-VALVED WITH NITINOL GUIDEWIRE BRAZIL. IT WAS REPORTED THAT THERE WAS DIFFICULTY EXTRAVASATING CONTRAST FROM THE CATHETER POSSIBLE DUE TO IMPROPER POSITIONING. DUE TO THIS ISSUE, THE PICC WAS REMOVED AND REPLACED. THERE IS NO REPORT OF PATIENT HARM, OR ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24505714 ↗MalfunctionFeb 12, 2026Separation Failure
AN END-USER EXPERIENCED AN ISSUE WITH A GUIDEWIRE FROM A BIOFLO MIDLINE 4F SL-20CM MAX STERILE BARRIER NURSING KIT W/ TWO NITINOL GUIDEWIRE PG. IT WAS REPORTED THAT, AFTER MIDLINE INSERTION, RESISTANCE WAS FELT WHILE PULLING THE GUIDEWIRE BACK THROUGH THE SHEATH. THE ENTIRE SHEATH WAS PULLED FROM THE PATIENT, AND NO PRODUCT WAS RETAINED. UPON INSPECTION OF THE COMPONENTS REMOVED FROM THE PATIENT, THE GUIDEWIRE COULD NOT BE ADVANCED BACK THROUGH THE SHEATH AND HAD CAUSED DAMAGE TO THE INTRODUCER DURING ATTEMPTED WITHDRAWAL. THERE WERE NO ADVERSE EFFECTS OR PATIENT HARM REPORTED BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322902 ↗MalfunctionFeb 12, 2026Crack
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 4F SL-55CM CATHETER KIT VALVED. IT WAS REPORTED THAT APPROXIMATELY 4 WEEKS POST PLACEMENT, THE PICC WAS REMOVED AND REPLACED DUE TO A HUB CRACK. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322660 ↗MalfunctionJan 20, 2026Fracture; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 4F SL 55CM MST-70 KIT NON-VALVED. DURING PICC PLACEMENT, THE STAINLESS STEEL GUIDEWIRE FRACTURED INTO TWO SEPARATE PIECES INSIDE THE PATIENT. THE WIRE HAD UNRAVELED PRIOR TO FRACTURING DUE TO THE EXTENDED TIME OF MANIPULATING THE WIRE AND TRYING TO FREE IT FROM THE COLLATERAL. THEY WERE UNABLE TO REMOVE THE RETAINED FRAGMENT FROM THE PATIENT'S RIGHT ARM WITHIN THE COLLATERAL VEIN CONNECTED TO THE BRACHIAL VEIN. THE COLLATERAL WAS SMALL AND TORTUOUS, AND HAD SPASMED. THEY BELIEVE THE FRAGMENT WILL NOT MIGRATE FROM THAT POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS INFORMED OF THE EVENT AND REPORTED TO HAVE NO CONCERNS AT THAT TIME. IT HAD BEEN REPORTED THE PATIENT HAD A NICKEL ALLERGY. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24116888 ↗MalfunctionJan 13, 2026Crack
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A BIOFLO DURAMAX 15.5F 28CM DUAL VALVE SHEATH BASIC KIT. DURING A DIALYSIS TREATMENT, AN AIR LEAK (MICROBUBBLES) CAUSED THE ALARM TO GO OFF. THE CATHETER WAS TESTED BY CLAMPING THE CATHETER AND AIR WAS ABLE TO BE ASPIRATED IN THE ARTERIAL LIMB. DUE TO THIS, THE DIALYSIS TREATMENT WAS STOPPED. THE CATHETER WAS SURGICALLY REPLACED TWO DAYS LATER UNDER LOCAL ANESTHESIA, AND REGULAR DIALYSIS WAS RESUMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058338 ↗
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 13, 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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