Turbo-Ject G56196Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002561960), received between Nov 6, 2014 and Sep 29, 2021 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2021Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE HUB OF A TURBO-JECT POWER INJECTABLE WAS LEAKING AND/OR SEPARATED. AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED. THE DEVICE WAS PLACED IN THE PATIENT'S RIGHT ARM FOR ADMINISTRATION OF MEDICATION. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548352 ↗
• InjuryAug 25, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE LINE OF A TURBO-JECT POWER INJECTABLE DEVICE SEPARATED FROM THE HUB. FOLLOWING IMPLANTATION IN THE PATIENT'S ARM ON (B)(6) 2019, THE PATIENT LEFT THE HOSPITAL WITH A MICROCLAVE AND "LEAFLET AS PER IFU". LATER ON, THE PATIENT'S MOTHER REPORTED TO THE PHYSICIAN THAT THE "TONE SHAFT OF THE DOUBLE LUMEN CATHETER IS BROKEN". THE DEVICE WAS REMOVED ON (B)(6) 2020 AND REPLACED WITH A DOUBLE LUMEN CATHETER, WHICH WAS CHOSEN DUE TO THE UNAVAILABILITY OF ANOTHER SINGLE LUMEN CATHETER. THIS INCIDENT OCCURRED AT THE PATIENT'S HOME. THE PATIENT USES THE DEVICE FOR NUTRITION AND WAS REPORTED TO BE "NOT IN GOOD CONDITION, CAN WALK AROUND 50 METERS". THOUGH THE USER FACILITY PROVIDED THE PATIENT AND HER MOTHER WITH A MICROCLAVE AND PATIENT BROCHURE, IT WAS REPORTED THAT THEY ARE NOT USING THEM. IT WAS ALSO REPORTED THAT THE PATIENT IS NOT BEING TREATED AT THE USER FACILITY DUE TO COVID-19. ANOTHER EVENT REGARDING THIS PATIENT IS ALSO REPORTED UNDER PATIENT IDENTIFIER (B)(6). NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Code Available

  MAUDE report 10449400 ↗
• MalfunctionSep 16, 2019Break; Break

  IT WAS REPORTED THAT A TURBO-JECT POWER INJECTABLE DEVICE WAS BEING USED ON A (B)(6) PATIENT WHEN THE "FITTING BETWEEN THE TUBING OF THE PICC LINE AND THE TUBING CARRYING THE PERFUSION BAGS" BROKE AFTER 38 DAYS OF USE. IT WAS ALSO REPORTED THAT THERE WAS NO DIFFICULTY DURING PLACEMENT OF THE DEVICE. THIS OCCURRED AFTER THE PATIENT HAD BEEN RELEASED FROM HOSPITAL CARE. THIS DEVICE HAD BEEN INSERTED IN PLACE OF A DIFFERENT DEVICE FOLLOWING THE OCCURRENCE OF THE SAME FAILURE MODE (CAPTURED IN AN ADDITIONAL REPORT WITH PATIENT IDENTIFIER: (B)(6), MFG REPORT REFERENCE #: (B)(4)). ULTIMATELY, THE DEVICE WAS REMOVED AT THE HOSPITAL AND NOT REPLACED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER, AS IT WAS NOT RETAINED BY THE FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9071704 ↗
• InjuryOct 27, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE INTERNATIONAL CUSTOMER REPORTED THAT WHEN THE INTRODUCER PORTION OF THE TURBO-JECT POWER INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WAS BEING INTRODUCED INTO THE VESSEL OF THE PATIENT'S ARM, IT OPENED UP INSIDE THE VESSEL, WHICH RESULTED IN DAMAGE TO THE INTIMA PORTION OF THE VESSEL WALL, PAIN, AND A LENGTHENED PROCEDURE TIME. A SECOND DEVICE HAD TO BE OPENED TO CONTINUE THE PROCEDURE. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: Pain; Tissue Damage

  MAUDE report 6984085 ↗
• MalfunctionOct 5, 2017Material Deformation; Material Deformation

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A ROUTINE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE INSERTION, THE OPERATOR OF THE TURBO-JECT POWER INJECTABLE DEVICE ATTEMPTED TO ADVANCE THE SHEATH INTO THE PATIENT AND WAS UNABLE TO DO SO. UPON THE RETRACTION OF THE DEVICE FOR EXAMINATION, THE OPERATOR REPORTEDLY OBSERVED A SMALL PROTRUSION OF AN UNSPECIFIED NATURE COMING FROM THE SHEATH. ANOTHER SHEATH WAS USED FROM A DIFFERENT PICC LINE SET. THE PROCEDURE CONTINUED WITH NO FURTHER COMPLICATIONS REPORTED, AND THE CUSTOMER CONFIRMED THAT THE PICC LINE FROM THE ORIGINAL KIT COULD STILL BE INSERTED INTO THE PATIENT AS ORIGINALLY INTENDED WITH NO PATIENT ADVERSE EVENTS. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6918055 ↗
• MalfunctionSep 21, 2017Split

  THE DEVICE WAS IN USE IN THE PATIENT WHEN IT WAS NOTED THAT THE DEVICE HAS A SPLIT IN ONE OF THE LUMENS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6882026 ↗
• InjurySep 20, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE INTERNATIONAL CUSTOMER REPORTED THAT, FOLLOWING THE IMPLANTATION OF THE TURBO-JECT POWER INJECTABLE PICC (PERIPHERALLY INSERTED VENOUS CATHETER) ON (B)(6) 2017, IT WAS SUBSEQUENTLY DISCOVERED IN EARLY AUGUST TO BE LEAKING BLOOD ABOVE THE WINGS OF THE DEVICE. DESPITE THE BLOOD LEAK, THERE WAS NO EVIDENCE OF INFECTION, AND NO ADVERSE EVENTS REPORTEDLY OCCURRED; HOWEVER, ADDITIONAL MEDICAL INTERVENTION IN THE FORM OF THE REMOVAL AND REPLACEMENT OF THE PICC LINE ON (B)(6) 2017 WAS NECESSITATED BY THE ISSUE. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE ARE NOT KNOWN. THE PRODUCT HAS BEEN RETURNED; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Code Available

  MAUDE report 6879873 ↗
• InjurySep 15, 2017Detachment Of Device Component; Material Separation

  WHILE IN USE IN A JUGULAR THROMBOSIS PATIENT FOR 2 MONTHS, THE PICC LINE SEPARATED FROM THE HUB. THE PICC LINE WAS PLACED DO TO DIFFUSE LARGE B-CELL LYMPHOMA WITH CHEMOTHERAPY. THE RADIOLOGIST DID NOT KNOW WHO TOOK CARE OF PICC MAINTENANCE AND WHICH PROTOCOL HAS BEEN FOLLOWED. THERE IS NO INFORMATION ON HOW THIS COULD HAVE HAPPENED. ACCORDING TO THE RADIOLOGIST, THE PATIENT REPORTED THAT HE "WOKE UP AND THE HUB WAS TORN OFF." THE LINE WAS RETRIEVED OVER A WIRE GUIDE AND REPLACED WITH A NEW PICC LINE.

  Patient problems: No Code Available

  MAUDE report 6868482 ↗
• MalfunctionSep 1, 2016Break; Break

  IT WAS REPORTED THE GUIDE BROKE AT THE END OF THE OPERATION. NO OTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT SUBMISSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5920492 ↗
• InjuryNov 6, 2014Material Separation

  THE FINE WIRE OF THE SELDINGER STYLE PICC LINE INSERTION KIT SPLIT IN THE PT'S VEIN. A SMALL HAIR'S BREADTH SECTION SEPARATED. THE FACILITY WAS ABLE TO RETRIEVE THE LOOSE SEGMENT, BUT THE PROCEDURE HAD TO BE ABANDONED AS THE VEIN WAS NOT USABLE AFTERWARDS.

  Patient problems: Foreign body, removal of

  MAUDE report 4254649 ↗