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Turbo-Ject G55883Recalls & reported problems

Cook Incorporated · Turbo-Ject PICC Set Power Injectable Polyurethane Peripherally Inserted Central Venous Catheter · Class 2 · Implant

All models of Turbo-Ject (40)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
19
Deaths reported
0
Injuries reported
16
Recalls naming it
0

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00827002558830), received between Jun 30, 2016 and Jun 6, 2019 — classified as 16 injuries, 3 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

Device problems

  • Crack6
  • Material Separation6
  • Leak/Splash4
  • Fluid/Blood Leak3
  • Break1
  • Disconnection1
  • Fracture1
  • Material Frayed1

Patient problems

  • No Code Available15
  • No Known Impact Or Consequence To Patient5
  • Sedation1

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 6, 2019Material Separation; Material Separation

    IT WAS REPORTED THAT THE HUB OF A TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER DETACHED COMPLETELY FROM THE DEVICE. THE PATIENT REQUIRED HOSPITAL ADMISSION THROUGH THE EMERGENCY DEPARTMENT FOR EXCHANGE OF THE LINE DUE TO TAKE PLACE THE FOLLOWING DAY. AFTER A SUCCESSFUL EXCHANGE OF THE LINE, THE PATIENT WAS DISCHARGED. AS REPORTED, THERE WERE NO ADVERSE EFFECTS EXPERIENCED BY THE PATIENT DUE TO THIS OCCURRENCE.

    Patient problems: No Code Available

    MAUDE report 8675721 ↗
  • InjuryJun 6, 2019Crack; Material Separation; Crack; Material Separation

    ADDITIONAL INFORMATION RECEIVED ON 21AUG2019, THE CUSTOMER STATED THAT ALL OF THE LINES HAD A PARTIAL DISCONNECTION FROM THE CLEAR TUBING TO THE HUB. IN A FEW CASES, THE HUBS WERE COMPLETELY DISCONNECTED. THE LEAKS WERE IDENTIFIED WHERE THE HUB AND CLEAR LINE MEET. PHOTOS WERE PROVIDED BY THE CUSTOMER AND CONFIRMED THE EXTENSION TUBE TO BE PARTIALLY OR FULLY SEPARATED FROM THE HUB. THE CONCLUSIONS DRAWN AT THE END OF THE PREVIOUS DEVICE INVESTIGATION REMAIN UNCHANGED BY THE ADDITIONAL INFORMATION.

    Patient problems: No Code Available

    MAUDE report 8675640 ↗
  • InjuryJun 6, 2019Crack; Material Separation; Crack; Material Separation

    IN ADDITIONAL INFORMATION RECEIVED ON 21AUG2019, THE CUSTOMER STATED THAT ALL OF THE LINES HAD A PARTIAL DISCONNECTION FROM THE CLEAR TUBING TO THE HUB. IN A FEW CASES, THE HUBS WERE COMPLETELY DISCONNECTED. THE LEAKS WERE IDENTIFIED WHERE THE HUB AND CLEAR LINE MEET. PHOTOS WERE PROVIDED BY THE CUSTOMER AND CONFIRMED THE EXTENSION TUBE TO BE PARTIALLY OR FULLY SEPARATED FROM THE HUB. THE CONCLUSIONS DRAWN AT THE END OF THE PREVIOUS DEVICE INVESTIGATION REMAIN UNCHANGED BY THE ADDITIONAL INFORMATION.

    Patient problems: No Code Available

    MAUDE report 8675152 ↗
  • InjuryApr 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Patient problems: No Code Available

    MAUDE report 8535761 ↗
  • InjuryApr 10, 2018Leak/Splash; Leak/Splash

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Patient problems: No Code Available

    MAUDE report 7416736 ↗
  • MalfunctionMar 19, 2018Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

    THE INTERNATIONAL CUSTOMER REPORTED THAT THE TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LEAKED AT THE JUNCTION OF THE PURPLE HUB AND THE CLEAR TUBING ON THE DISTAL END OF THE DEVICE. THE PICC LINE WAS UTILIZED AT LEAST WEEKLY FOR INFUSIONS OF BLOOD PRODUCTS AND CHEMOTHERAPY, AS WELL AS BLOOD DRAWS. THE PRODUCT PROBLEM OCCURRED APPROXIMATELY 180 DAYS AFTER INITIAL PLACEMENT AND NECESSITATED THE USE OF ADDITIONAL ANESTHETIC AND THE PLACEMENT OF A NEW DEVICE IN AN ADDITIONAL PROCEDURE. THE COMPLAINT 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 Code Available

    MAUDE report 7348464 ↗
  • InjuryJan 26, 2018Disconnection; Disconnection

    THE CUSTOMER REPORTED THAT A "FULL DISCONNECT" [SIC] OF THE TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) LINE OCCURRED. THE CUSTOMER IS UNSURE OF THE CIRCUMSTANCES SURROUNDING THE SEPARATION. THE PICC LINE WAS PLACED (B)(6) 2017 IN THE PATIENT'S ARM FOR FACTOR INFUSIONS. ON (B)(6) 2018, THE ISSUE WAS NOTED, AND ON THE (B)(6) 2018, THE LINE WAS REPLACED. NO FURTHER ISSUES WERE ENCOUNTERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS YET BEEN PROVIDED. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

    Patient problems: No Code Available

    MAUDE report 7223293 ↗
  • InjuryJan 24, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT, WHILE THE PATIENT WAS AT HOME, IT WAS DISCOVERED THAT THEIR PREVIOUSLY INSERTED TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LINE WAS LEAKING FROM THE PURPLE HUB. THE HUB ITSELF DID NOT APPEAR TO BE CRACKED. THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM ON (B)(6) 2018, AND THE LINE WAS ULTIMATELY EXCHANGED ON (B)(6) 2018. . THE DEVICE WAS ORIGINALLY INSERTED INTO THE PATIENT'S ARM ON (B)(6) 2017 TO DELIVER INTRAVENOUS (IV) ANTIVIRAL MEDICATION FOLLOWING A RECENT TRANSPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN PROVIDED. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

    Patient problems: No Code Available

    MAUDE report 7217365 ↗
  • InjuryJul 28, 2017Leak/Splash; Leak/Splash

    CUSTOMER REPORTED THAT A PATIENT RECEIVED A TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER FOR AN UNSPECIFIED INDICATION. THE DATE OF IMPLANT WAS NOT PROVIDED. THE CUSTOMER STATED THAT THE " PATIENT AWOKE TO A LEAKING LINE THIS AM, NO TRAUMA TO LINE BUT LINE WAS CRACKED AT THE HUB." THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Patient problems: No Code Available

    MAUDE report 6751044 ↗
  • InjuryJul 18, 2017Leak/Splash; Leak/Splash

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT RECEIVED A TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER ON (B)(6) 2016 FOR CHEMOTHERAPY. THE CUSTOMER STATES THERE IS A LEAK ON THE EXTERNAL TUBE OF THE CATHETER. THE LEAK IS FROM A TEAR IN THE CATHETER AT THE HUB. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2017. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Patient problems: No Code Available

    MAUDE report 6720916 ↗
  • InjuryMay 2, 2017Crack; Crack

    PATIENT HAD A TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER IMPLANTED ON (B)(6) 2016 FOR ADMINISTRATION OF HOME BASED TOTAL PARENTERAL NUTRITION (TPN). THE CUSTOMER REPORTED THAT THE PATIENTS' MOTHER CONNECTED THE PATIENT FOR TPN TREATMENT. WETNESS WAS OBSERVED ON THE PATIENTS' ARM ONE HOUR AFTER STARTING TPN TREATMENT. A SPLIT AT THE HUB WAS OBSERVED AS THE SOURCE OF THE WETNESS. THE PATIENT WAS RETURNED TO THE HOSPITAL AND UNDERWENT DEVICE EXPLANT AND A TUNNELED CATHETERIZATION ON (B)(6) 2017. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Patient problems: No Code Available

    MAUDE report 6536487 ↗
  • InjuryMay 1, 2017Crack; Crack

    CUSTOMER REPORTED THAT A TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER WAS IMPLANTED ON (B)(6) "017". A CRACK IN THE HUB WAS OBSERVED ON (B)(6) 2017. THE DEVICE WAS COMPLETELY EXPLANTED AND REPLACED WITH A NEW DEVICE. NO FURTHER EVENT INFORMATION WAS PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Patient problems: No Code Available

    MAUDE report 6533353 ↗
  • InjuryDec 27, 2016Leak/Splash; Leak/Splash

    IT WAS NOTICED THAT THE PATIENT'S PICC LINE WAS LEAKING AT THE PATIENT'S HOME. THE PATIENT HAD A TPN RUNNING THROUGH THE LINE. THE PATIENT CAME INTO THE HOSPITAL AND THE USER FACILITY EXCHANGED THE PICC FOR NEW ONE UNDER GENERAL ANESTHESIA.

    Patient problems: No Code Available

    MAUDE report 6206368 ↗
  • InjuryDec 16, 2016Break; Break

    IT WAS REPORTED THERE WAS BREAKAGE OF THE EXTERNAL PART OF THE CATHETER AT THE CONNECTION OF THE TUBES. THE CATHETER WAS REPLACED WITH A SIMILAR DEVICE . ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Code Available

    MAUDE report 6182472 ↗
  • MalfunctionAug 3, 2016Material Frayed; Material Frayed

    IT WAS REPORTED THAT WHILE ATTEMPTING TO PLACE THE PICCLINE ARTERIAL CATHETER IN THE PAEDIATRIC INTENSIVE CARE UNIT, THERE WAS DIFFICULTY IN GETTING THE WIRE GUIDE THROUGH THE NEEDLE. THE DEVICE WAS GENTLY PULLED BACK OUT BY THE PHYSICIAN, THE WIRE GUIDE WAS REINFORCED BUT STILL ENCOUNTERED RESISTANCE. THE DECISION WAS MADE TO COMPLETELY REMOVE THE WIRE GUIDE, WHICH CAME OUT COMPLETELY FRAYED. A NEW PLACEMENT COMPLETED WITH ANOTHER CATHETER FROM THE SAME LOT ENCOUNTERED NO ISSUES. THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED BY THE REPORTER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5843839 ↗
  • MalfunctionJul 20, 2016Crack; Crack

    THE 3 FR PICC LINE WAS PLACED IN THE PATIENT ON (B)(6) 2016 FOR ANTIBIOTIC TREATMENT. ON (B)(6) 2016, THE LINE WAS NOTED TO HAVE CRACKED (1820334-2016-00661). THE REPORTER STATES THE SAME ISSUE OCCURRED WITH A 4 AND 5FR DOUBLE LUMEN PICC'S. THIS IS THE PATIENT'S SECOND MALFUNCTION, THE FIRST WAS IN (B)(6) 2016, ACCORDING TO THE PATIENT'S MOTHER. THE PATIENT ONLY HAD IT IN FOR A WEEK FOR ANTIBIOTICS AT THAT TIME. PATIENT RETURNED ON (B)(6) 2016 TO HAVE THE DEVICE REPLACED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5808366 ↗
  • InjuryJun 30, 2016Material Separation; Material Separation

    AFTER PLACEMENT OF A PICC LINE ON A (B)(6) YEAR OLD MALE PATIENT, THE LINE RUPTURED BETWEEN THE EXTENSION AND THE FINAL CONNECTION. THE PATIENT REQUIRED SEDATION AND A NEW PICC LINE IMPLANTED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5761152 ↗
  • InjuryJun 30, 2016Material Separation; Material Separation

    AFTER PLACEMENT OF A PICC LINE ON A (B)(6) YEAR OLD MALE PATIENT, THE LINE RUPTURED BETWEEN THE EXTENSION AND THE FINAL CONNECTION. THE PATIENT REQUIRED SEDATION AND A NEW PICC LINE IMPLANTED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Known Impact Or Consequence To Patient; Sedation

    MAUDE report 5761106 ↗
  • InjuryJun 30, 2016Material Separation; Material Separation

    AFTER PLACEMENT OF A PICC LINE ON A (B)(6) YEAR OLD MALE PATIENT, THE LINE RUPTURED BETWEEN THE EXTENSION AND THE FINAL CONNECTION. THE LINE WAS EXPLANTED SOMETIME IN (B)(6) 2016. THE PATIENT REQUIRED FURTHER SEDATION AND A NEW PICC LINE IMPLANTED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Code Available; No Known Impact Or Consequence To Patient

    MAUDE report 5761078 ↗

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