BioFlo 45883Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI H965458830), received between Aug 3, 2016 and Jun 14, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AN END USER REPORTED AN ISSUE WITH A CATHETER FROM A BIO-STABLE 5F DL-55CM IR-145 KIT VALVED WITH NITINOL GW KIT. APPROXIMATELY ONE WEEK AFTER PLACEMENT, THE PATIENT'S PICC WAS NOTED TO BE LEAKING AT THE PURPLE HUB CONNECTION. THE PICC WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124766 ↗
• MalfunctionMar 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIO-STABLE 5F DL-55CM IR-145 KIT,VALVED WITH NITINOL GW. IT WAS REPORTED THE LUER LOCK CONNECTORS ON A PATIENT'S PICC LINE BROKE. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537996 ↗
• MalfunctionMar 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIO-STABLE 5F DL-55CM IR-145 KIT, VALVED WITH NITINOL GW. IT WAS REPORTED THE LUER LOCK CONNECTORS ON A PATIENT'S PICC LINE BROKE. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537995 ↗
• MalfunctionAug 10, 2020Crack; Crack

  A CANCER CARE CLINICAL NURSE CONSULTANT REPORTED 2 OCCURRENCES OF BIOFLO PICCS FRACTURING AT THE HUB TO AN MSA TERRITORY MANAGER. IT IS BELIEVED THAT THE HUBS MAY HAVE FRACTURED DUE TO OVERTIGHTENING OF THE "BUNGS (NEEDLELESS CONNECTORS). THE PICC WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. THERE WAS NO HARM OF INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10388043 ↗
• MalfunctionAug 10, 2020Crack; Crack

  BIOFLO PICC # 2: A CANCER CARE CLINICAL NURSE CONSULTANT REPORTED 2 OCCURRENCES OF BIOFLO PICCS FRACTURING AT THE HUB TO AN MSA TERRITORY MANAGER. IT IS BELIEVED THAT THE HUBS MAY HAVE FRACTURED DUE TO OVERTIGHTENING OF THE "BUNGS (NEEDLELESS CONNECTORS). THE PICC WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. THERE WAS NO HARM OF INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFATURER FOR A DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10387989 ↗
• MalfunctionJun 4, 2020Obstruction of Flow; Obstruction of Flow

  A CLINICAL NURSE EDUCATOR REPORTED THAT THIS BIO-STABLE PICC LINE HAD ALTEPLASE (CATHFLO) INDWELLING, IN BOTH PORTS, DUE TO AN INABILITY TO ASPIRATE BLOOD. UPON ASPIRATION OF INDWELLING MEDICATION AND BLOOD ASPIRATE AS PER PROTOCOL, WHITE/CREAMY ORB-LIKE GRANULES WERE NOTED IN ASPIRATED BLOOD (NO BLOOD CLOTS VISIBLE)EVEN WITH SUBSEQUENT, MULTIPLE ASPIRATED SAMPLES. THE GRANULES CLUMP TOGETHER IN A SYRINGE BUT DO NOT STAY IN CLUMPS WHEN EXPELLED ONTO GAUZE. GRANULES APPEAR TO IMMEDIATELY DISINTEGRATE WHEN TOUCHED BETWEEN GLOVED FINGERS. ULTIMATELY, THE PATIENT HAD THE PICC REMOVED AND REPLACED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10118848 ↗
• MalfunctionJun 4, 2020Obstruction of Flow; Obstruction of Flow

  A CLINICAL NURSE EDUCATOR REPORTED THAT THIS BIO-STABLE PICC LINE HAD ALTEPLASE (CATHFLO) INDWELLING, IN BOTH PORTS, DUE TO AN INABILITY TO ASPIRATE BLOOD. UPON ASPIRATION OF INDWELLING MEDICATION AND BLOOD ASPIRATE AS PER PROTOCOL, WHITE/CREAMY ORB-LIKE GRANULES WERE NOTED IN ASPIRATED BLOOD (NO BLOOD CLOTS VISIBLE)EVEN WITH SUBSEQUENT, MULTIPLE ASPIRATED SAMPLES. THE GRANULES CLUMP TOGETHER IN A SYRINGE BUT DO NOT STAY IN CLUMPS WHEN EXPELLED ONTO GAUZE. GRANULES APPEAR TO IMMEDIATELY DISINTEGRATE WHEN TOUCHED BETWEEN GLOVED FINGERS. ULTIMATELY, THE PATIENT HAD THE PICC REMOVED AND REPLACED WHICH REQUIRED A PROLONGED HOSPITAL STAY. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10118830 ↗
• MalfunctionJan 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: BIOFLO PASV 5F DL - RN WENT TO PATIENT BEDSIDE AND NOTICED BLOOD EVERYWHERE FROM THE VALVE NO LONGER CONNECTED TO THE HUB. THE PICC WAS INITIALLY PLACED IN OCTOBER 2019 AND WAS NOTICED/REPLACED ON (B)(6) 2020. NO LOT NUMBER SINCE IT'S BEEN ROUGHLY 4 MONTHS. THE PICC WAS REMOVED AND REPLACED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9617315 ↗
• MalfunctionFeb 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY HOSPITAL IN (B)(6), FOLLOWING IMPLANTATION OF PICC IN PATIENT'S UPPER ARM, LEAKAGE WAS NOTED AT THE AREA OF THE HUB OVER SLEEVE. THE CATHETER WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS AND THE CATHETER WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8326027 ↗
• MalfunctionDec 4, 2018Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), INDWELLING BIOFLO PICC WAS REMOVED DUE TO A CRACKED HUB. THE USED CATHETER WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8129015 ↗
• MalfunctionDec 4, 2018Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), INDWELLING BIOFLO PICC WAS REMOVED DUE TO A CRACKED HUB. THE USED CATHETER WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8129012 ↗
• MalfunctionJul 9, 2018Backflow; Backflow

  AS REPORTED BY HOSPITAL IN (B)(6), AN IMPLANTED BIOFLO PICC WAS REMOVED FROM A PATIENT BECAUSE, "THE PICC LINE CONTINUES TO STREAM BLOOD BACK IN THE LUMEN." NO PATIENT INJURY WAS REPORTED. THE DEVICE FROM THE REPORTED INCIDENT HAS BEEN DISCARDED AT THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7669298 ↗
• MalfunctionAug 3, 2016Material Fragmentation; Material Fragmentation

  AS REPORTED, THE TIP OF AN ANGIOGRAPHIC GUIDEWIRE BROKE OFF WITHIN A PICC CATHETER DURING CATHETER PLACEMENT. BOTH DEVICES WERE ABLE TO BE REMOVED FROM THE PATIENT WITHOUT THE TIP MIGRATING OUT OF THE CATHETER. NO PATIENT INJURY OR COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5842945 ↗