Turbo-Ject G34516Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00827002345164), received between Apr 8, 2016 and Apr 19, 2022 — classified as 12 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Crack” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT UPON FLUSHING THE WHITE LUMEN OF A TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC, LEAKAGE WAS NOTED AT THE JUNCTION OF THE WHITE HUB AND TUBING. NO ADVERSE EFFECTS HAVE BEEN REPORTED AT THIS TIME. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140996 ↗
• MalfunctionDec 16, 2021Component Incompatible; Obstruction of Flow; Difficult to Advance; Component Incompatible; Obstruction of Flow; Difficult to Advance

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019740 ↗
• InjuryDec 10, 2020Crack; Crack

  IT WAS REPORTED THAT THE LINE OF A TURBO-JECT DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC CRACKED. CONSEQUENTLY, THE DEVICE HAD TO BE REMOVED AND REPLACED. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 10987374 ↗
• InjuryNov 16, 2020Fitting Problem; Fitting Problem

  NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 10844715 ↗
• InjuryNov 16, 2020Fitting Problem; Fitting Problem

  NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 10844583 ↗
• MalfunctionSep 4, 2020Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED ON 09SEP2020. THE WIRE GUIDE WAS NOT MANIPULATED THROUGH THE NEEDLE. THE BROKEN TIP WAS RETRIEVED FROM THE PATIENT; NO ADDITIONAL PROCEDURES WERE REQUIRED. A NEW DEVICE WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10494355 ↗
• InjuryJun 30, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IN ADDITIONAL INFORMATION RECEIVED ON 16JUL2020, IT WAS REPORTED THAT THE DEVICE WAS PLACED IN THE RIGHT BASILIC VEIN FOR CHEMOTHERAPY. THE DEVICE FAILED DURING TREATMENT, AND AT THE TIME OF THE CATHETER FRACTURE, AN INFUSION OF IV FLUIDS WAS BEING GIVEN THAT INCLUDED 0.45% NACL, 5% GLUCOSE, 20MMOL KCL AND 50MMOL NAHCO3. A PARTIAL SEPARATION WAS NOTED TO BE LOCATED JUST ABOVE THE WHITE LUMEN. THE DEVICE WAS IMPLANTED ON (B)(6) 2020 AND WAS EXPLANTED ON (B)(6) 2020. THE DEVICE WAS MAINTAINED WITH FLUSHING AND WEEKLY DRESSING CHANGES. HEPARINIZED SALINE 10U/ML WAS USED TO LOCK THE CATHETER. THE DEVICE WAS SECURED TO THE PATIENT USING A PICC STATLOCK FROM ANOTHER MANUFACTURER AND A TEGADERM IV ADVANCED DRESSING. NO ANTI-TAMPERING DEVICE WAS USED ON THE CATHETER. THE ACTIVITY LEVEL OF THE PATIENT WAS DESCRIBED AS "STANDARD FOR THAT AGE."

  Patient problems: No Code Available

  MAUDE report 10213532 ↗
• MalfunctionSep 18, 2019Material Rupture; Material Deformation; Material Rupture; Material Deformation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9083191 ↗
• InjuryJun 6, 2019Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 8674351 ↗
• MalfunctionNov 28, 2017Unraveled Material; Unraveled Material

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC FOR AN UNSPECIFIED INDICATION. THE GUIDE WIRE UNRAVELED AND 'HAS FALLEN APART' DURING PLACEMENT. THE WIRE WAS EXCHANGED FOR A NEW DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7062733 ↗
• MalfunctionSep 19, 2017Material Separation

  WHILE PREPARING FOR THE PROCEDURE, PRIOR TO PATIENT CONTACT, THE PURPLE HUB SEPARATED AT THE LUER FITTING. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6875083 ↗
• MalfunctionSep 13, 2017Difficult to Remove

  IT WAS REPORTED THAT DURING A PICC LINE REPLACEMENT, THE WIRE BECAME STUCK AND COULD NOT BE WITHDRAWN THROUGH THE CATHETER. THE PROCEDURE WAS COMPLETED BY PLACING THE PICC LINE THROUGH THE PEEL-AWAY SHEATH WITHOUT A WIRE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES AS A RESULT OF THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861038 ↗
• MalfunctionJun 26, 2017Unraveled Material; Unraveled Material

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC FOR AN UNSPECIFIED INDICATION. THE GUIDE WIRE UNRAVELED AND 'HAS FALLEN APART' DURING PLACEMENT. THE WIRE WAS EXCHANGED FOR A NEW DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6667137 ↗
• InjuryFeb 8, 2017Microbial Contamination of Device; Microbial Contamination of Device

  INTERNATIONAL CUSTOMER STATED IN A FOLLOW-UP TO A PREVIOUS INVESTIGATION THAT THE PATIENT HAD A PRIOR 'LINE INFECTION.' LINE WAS IMPLANTED TO PROVIDE THE PATIENT WITH PARENTERAL NUTRITION AND LIPIDS. NO DETAILS WERE PROVIDED RELATING TO THE INFECTION ONSET DATE OR RESOLUTION DATE. NO INFORMATION WAS PROVIDED RELATING TO CULTURE RESULTS AND SENSITIVITY. PATIENT WAS REPORTEDLY TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS. SPECIFIC ANTIBIOTIC INFORMATION WAS NOT PROVIDED. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED.

  Patient problems: Bacterial Infection

  MAUDE report 6312294 ↗
• InjuryFeb 3, 2017Fracture; Fracture

  INTERNATIONAL CUSTOMER REPORTED THAT A PREVIOUSLY IMPLANTED PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE USED TO PROVIDE PARENTERAL NUTRITION AND LIPIDS SNAPPED AT THE LUMEN END IN-SITU. THE DEVICE WAS EXPLANTED. AN UNSPECIFIED JELCO (TM) INTRAVENOUS CATHETER WAS PLACED TEMPORARILY UNTIL A NEW PICC COULD BE IMPLANTED. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED. NO DEVICE FRAGMENTS REMAINED IN THE PATIENT'S BODY FOLLOWING EXPLANT.

  Patient problems: No Code Available

  MAUDE report 6301350 ↗
• MalfunctionSep 13, 2016Fracture; Fracture

  THE VASCULAR ACCESS INSERTION NURSE HAS REPORTED THAT DURING CHEMOTHERAPY ADMINISTRATION THE PICC CATHETER WAS "FRACTURED" AND LEAKING AT THE JUNCTION BETWEEN THE HUBS AND THE CLEAR FLEXIBLE TUBING. THE PICC LINE WAS REPLACED WITH ANOTHER MANUFACTURERS PRODUCT TO CONTINUE TREATMENT. THE VASCULAR ACCESS TEAM REPORTED THE STAFF BEING UNABLE TO SAFELY REMOVE MAX PLUS CLEAR NEEDLESS CONNECTORS FOR THE COOK PICC LINES , ALL OTHER LINES WITHIN THE HOSPITAL REPORTEDLY WORK WITH THE SAME CONNECTOR OR PPV CAP NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5945720 ↗
• MalfunctionAug 25, 2016Crack; Crack

  A PATIENT OF UNKNOWN GENDER AND AGE, HAD A 4FR DBL LUMEN PICC THAT HAD TO BE REPLACED DUE TO CRACK IN THE LINE. DEVICE REPLACED IN (B)(6) 2016.

  Patient problems: No Code Available

  MAUDE report 5903840 ↗
• MalfunctionAug 9, 2016Crack; Crack

  IT WAS REPORTED DURING ANTIBIOTIC THERAPY THAT THE PURPLE HUB ON THE PICC LINE CRACKED. ALSO, THE NEEDLELESS CONNECTOR WAS HARD TO REMOVE AND REPLACE. THE PICC LINE WAS REMOVED AFTER 35 DAYS INSITU. IT WAS NOT REPLACED. THE PATIENT WAS PLACED ON ORAL ANTIBIOTICS.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 5858039 ↗
• InjuryJul 12, 2016Crack; Crack

  THE PICC LINE WAS PLACED IN THE PATIENT ON (B)(6) 2016. THE PATIENT BECAME INPATIENT ON (B)(6) 2016 AND THE PICC LINE WAS NOTED TO BE FUNCTIONING. ON (B)(6) 2016, IT WAS NOTED THAT THE PURPLE LINE HAD A CRACK AND WAS CLAMPED OFF. PATIENT HAD SLIPPED THE DAY PRIOR AND THE IV TUBING GOING INTO THE PICC WAS TUGGED. BOTH LUMENS WERE CHECKED AND FUNCTIONING. THE PICC LINE WAS REPLACED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5784989 ↗
• InjuryJul 8, 2016Crack; Crack

  THE FEMALE PATIENT WAS AT HOME AND BLOOD WAS POURING OUT OF HER LINE PER THE MOTHER. THE MOTHER OF THE PATIENT CLAMPED IT AND BROUGHT THE PATIENT INTO THE EMERGENCY DEPARTMENT (ED). THE PICC HAD BEEN PLACED IN THE ARM ON (B)(6) 2016. AN INSPECTION NOTED THE HUB WAS CRACKED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ALTHOUGH ADVISED THAT THE PATIENT HAD AN ADDITIONAL PROCEDURE; NO DETAILS WERE PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5778188 ↗
• InjuryJun 22, 2016Leak/Splash; Leak/Splash

  DURING A PICC LINE PLACEMENT, THE LINE WAS LEAKING AT THE PURPLE HUB. THE NURSE CLAMPED THE LINE AND IT WAS REPLACED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient; Underdose

  MAUDE report 5742702 ↗
• InjuryJun 17, 2016Fluid/Blood Leak; Fluid/Blood Leak

  THE PATIENT PRESENTED TO EO WITH ANOTHER ISSUE. UPICDS WAS USED TO INFUSE FOR APPROXIMATELY 14 HOURS BEFORE THEY NOTICED A SLIGHT LEAK AT HUB. PICC WAS PLACED ON (B)(6) 2016 AND NO ISSUES WERE NOTED UNTIL (B)(6) 2016. PICC LINE WAS REPLACED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Fluid Discharge

  MAUDE report 5733347 ↗
• InjuryApr 8, 2016Difficult to Remove; Uncoiled; Difficult to Remove; Uncoiled

  A (B)(6) YEAR OLD MALE PATIENT WAS UNDERGOING A VENOGRAM PROCEDURE. AS HE HAD AN INFECTION; WHICH REQUIRED ANTIBIOTICS, A PICC LINE WAS PLACED IN THE LEFT ARM. WHEN THE PHYSICIAN TRIED TO REMOVE WIRE AFTER INSERTION OF THE CATHETER, IT WAS STUCK. THE VENOGRAM SHOWED THAT THE AXILLARY VEIN HAD OCCLUDED AND THE SOFT TIP HAD GONE THROUGH THE VEIN. DILATOR WAS REMOVED AND WIRE WAS TRIMMED AND TAPED SO VENOGRAPH COULD BE COMPLETED. THE SURGEONS CONTEMPLATED SEVERAL POSSIBILITIES TO REMOVE WIRE, HOWEVER THEY WERE ABLE TO REMOVE IT BY USING FORCE. IT WAS FOUND THAT THE WIRE HAD UNCOILED FROM THE SOFT DISTAL TIP TO THE START OF THE FIRM PART. THE PATIENT'S ANATOMY WAS REPORTED TO HAVE BEEN TORTUOUS AND THE VEIN WAS OCCLUDED. THE PATIENT IS REPORTED TO BE DOING WELL. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AFTER TO THIS OCCURRENCE.

  Patient problems: Perforation of Vessels

  MAUDE report 5563579 ↗