Turbo-Ject G55884Recalls & 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
- 16
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002558847), received between Oct 6, 2016 and Sep 19, 2017 — classified as 10 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (9 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
- Leak/Splash9
- Fracture6
- Break4
- Crack1
- Fluid/Blood Leak1
- Material Separation1
- Split1
Patient problems
- No Code Available12
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2017Crack; Leak/Splash
THE CUSTOMER REPORTED THAT THE PICC WAS FOUND TO BE LEAKING EIGHT DAYS AFTER IMPLANTATION. IT WAS REMOVED AND REPLACED WITH A PERIPHERAL IV CATHETER. UPON INSPECTION, IT WAS FOUND TO BE CRACKED BETWEEN THE CATHETER AND HUB. NO PART OF THE DEVICE WAS LEFT IN THE PATIENT, AND THERE WERE NO FURTHER INJURIES ASIDE FROM THE REPLACEMENT PROCEDURE.
Patient problems: No Code Available
MAUDE report 6875271 ↗InjuryAug 28, 2017Break; Break
THE INTERNATIONAL CUSTOMER REPORTED THAT THE PICC LINE BROKE AT THE JUNCTION BETWEEN THE CATHETER AND THE HUB, WHICH NECESSITATED AN ADDITIONAL PROCEDURE. THE DETAILS REGARDING THE ADDITIONAL PROCEDURE WERE NOT SUPPLIED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Code Available
MAUDE report 6824596 ↗InjuryJun 23, 2017Split; Split
INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A TURBO-JECT OVER-THE-WIRE SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER FOR AN UNSPECIFIED INDICATION. THE CUSTOMER REPORTED THAT THE CATHETER SPLIT. THE EVENT OCCURRED WHILE THE PATIENT WAS AT HOME. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING UP TO THE EVENT ARE NOT KNOWN. THE PATIENT RETURNED TO THE HOSPITAL AND UNDERWENT GENERAL ANESTHESIA FOR REMOVAL AND REPLACEMENT OF THE DEVICE. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 6663844 ↗MalfunctionFeb 23, 2017Break; Break
INTERNATIONAL CUSTOMER REPORTED THAT A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) BROKE. THE DEVICE REPORTEDLY HAD A "SHORT DWELL TIME" OF SEVEN (7) DAYS; THE SPECIFIC IMPLANT DATE WAS NOT PROVIDED. THE NURSE REPORTEDLY WENT TO GIVE MEDICATION TO THE "ALMOST (B)(6)" PATIENT AND FOUND THAT THE FLUID WAS LEAKING OUT OF THE CATHETER. THE BREAK OCCURRED AT THE JUNCTION OF THE DISTAL PURPLE HUB AND THE CATHETER. INFORMATION PROVIDED INDICATES THAT THE PATIENT UNDERWENT COMPLETE DEVICE EXPLANT UNDER GENERAL ANESTHESIA. THE DEVICE WAS REPLACED WITH AN UNSPECIFIED PERIPHERAL CANNULA. INFORMATION ALSO RECEIVED FROM THE AUSTRALIA THERAPEUTIC GOODS ADMINISTRATION (TGA) INDICATES THAT THE DEVICE WAS REWIRED UNDER GENERAL ANESTHESIA. THE SEQUENCE OF EVENTS TO ADDRESS THIS OCCURRENCE IS UNCLEAR. NO UNINTENDED FOREIGN BODIES WERE RETAINED WITHIN THE PATIENT'S BODY. NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED. .
Patient problems: No Code Available
MAUDE report 6352999 ↗MalfunctionJan 19, 2017Material Separation; Material Separation
CUSTOMER REPORTED TO THE (B)(6) THERAPEUTIC GOODS ADMINISTRATION REGULATORY AGENCY AND SUBSEQUENTLY TO THE MANUFACTURER ¿THAT THE DEVICE HAD SNAPPED BETWEEN THE CATHETER AND PURPLE BUNG ATTACHMENT END OF LINE". THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS PREVIOUSLY IMPLANTED ON AN UNSPECIFIED DATE. THE PATIENT ¿REQUIRED A REINSERTION OF PICC DURING A PLANNED PROCEDURE (REVERSAL OF STOMA).¿ A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED.
Patient problems: No Code Available
MAUDE report 6264409 ↗MalfunctionJan 11, 2017Fluid/Blood Leak; Fluid/Blood Leak
WHEN THE NURSE WENT TO ADMINISTER MEDICATION FOR THE MALE PATIENT THEY FOUND THE INFUSATE WAS LEAKING OUT AT THE CATHETER ATTACHMENT JUNCTION WITH THE LUMEN. THE MEDICATION WAS OMITTED, DEVICE WAS REMOVED AND PATIENT WAS DISCHARGED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6244067 ↗InjuryDec 20, 2016Break; Break
IT WAS REPORTED THE NURSE NOTICED THE PICC LINE WAS BROKEN WHEN SHE WENT TO ADMINISTER MEDICATION. THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE AND FLUOROSCOPY TO PLACE A NEW LINE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Code Available
MAUDE report 6191219 ↗InjuryDec 8, 2016Break; Break
IT WAS REPORTED A PICC LINE PLACED IN THE RIGHT BASILIC FOR EIGHT DAYS TO ADMINISTER INTRAVENOUS ANTIBIOTICS WAS BROKEN AT THE CONNECTION BETWEEN THE CATHETER AND THE ADAPTER. THE LINE WAS REMOVED IN AN ADDITIONAL PROCEDURE AND A NEW PICC LINE WAS INSERTED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 6156262 ↗InjuryDec 8, 2016Leak/Splash; Leak/Splash
IT WAS REPORTED A PICC LINE PLACED IN THE RIGHT BRACHIAL FOR TWELVE DAYS TO ADMINISTER INTRAVENOUS ANTIBIOTICS WAS LEAKING AT THE DISTAL END OF THE LINE. THE LINE WAS REMOVED IN AN ADDITIONAL PROCEDURE AND A NEW PICC LINE WAS INSERTED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 6156255 ↗InjuryDec 8, 2016Leak/Splash; Leak/Splash
IT WAS REPORTED A PICC LINE PLACED IN THE RIGHT BASILICA FOR TWENTY FOUR DAYS TO ADMINISTER INTRAVENOUS ANTIBIOTICS WAS LEAKING AT THE DISTAL END OF THE LINE. THE LINE WAS REMOVED IN AN ADDITIONAL PROCEDURE AND A NEW PICC LINE WAS INSERTED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Code Available
MAUDE report 6156126 ↗MalfunctionOct 6, 2016Fracture; Leak/Splash; Fracture; Leak/Splash
IT WAS REPORTED THE (B)(6) MALE PATIENT HAD A PICC LINE IN PLACE FOR 7 DAYS TO ADMINISTER IV ANTIBIOTIC THERAPY WHEN IT WAS NOTED THAT THE LINE WAS FRACTURED AND LEAKING AT THE JUNCTION BETWEEN THE HUB AND THE CLEAR FLEXIBLE TUBING. THE DOCTOR REPORTED THERE HAVE BEEN NO CHANGES IN CLINICAL PRACTICE WITH REGARDS TO CARE, MAINTENANCE OR INSERTION OF THE DEVICE. 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 6003947 ↗InjuryOct 6, 2016Fracture; Leak/Splash; Fracture; Leak/Splash
INFORMATION WAS PROVIDED THAT THE (B)(6) MALE PATIENT HAD A PICC LINE IN PLACE FOR 19 DAYS TO ADMINISTER IV ANTIBIOTIC THERAPY WHEN IT WAS NOTED THAT LINE WAS FRACTURED AND LEAKING BETWEEN THE PURPLE HUB AND THE NEEDLELESS CONNECTOR. THE DOCTOR REPORTED THERE HAVE BEEN NO CHANGES IN CLINICAL PRACTICE WITH REGARDS TO CARE, MAINTENANCE OR INSERTION OF THE DEVICE. REPORTEDLY A PERIPHERAL CANNULA CATHETER WAS INSERTED TO CONTINUE THE IV THERAPY TREATMENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 6003936 ↗MalfunctionOct 6, 2016Fracture; Leak/Splash; Fracture; Leak/Splash
INFORMATION WAS PROVIDED THAT THE (B)(6) FEMALE PATIENT HAD A PICC LINE IN PLACE FOR 9 DAYS TO POTENTIALLY ADMINISTER CHEMOTHERAPY WHEN IT WAS NOTED THAT THE LINE WAS FRACTURED AND LEAKING AT THE JUNCTION BETWEEN THE HUB AND THE CLEAR FLEXIBLE TUBING. THE LINE WAS REMOVED, BUT WAS NOT REPLACED WITH A NEW LINE AS TREATMENT HAD NOT YET STARTED. THE DOCTOR REPORTED THERE HAVE BEEN NO CHANGES IN CLINICAL PRACTICE WITH REGARDS TO CARE, MAINTENANCE OR INSERTION OF THE DEVICE. REPORTEDLY THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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 6003233 ↗InjuryOct 6, 2016Fracture; Leak/Splash; Fracture; Leak/Splash
THE (B)(6) MALE PATIENT HAD A PICC LINE INSERTED IN THE RIGHT BASILICA VEIN FOR 27 DAYS TO ADMINISTER IV THERAPY. IT WAS REPORTED THAT THE LINE FRACTURED AND BEGAN LEAKING AT THE JUNCTION BETWEEN THE HUB AND THE CLEAR FLEXIBLE TUBING. THE DOCTOR REPORTED THERE HAVE BEEN NO CHANGES IN CLINICAL PRACTICE WITH REGARDS TO CARE, MAINTENANCE OR INSERTION OF THE DEVICE. REPORTEDLY THE PATIENT DID REQUIRE ADDITIONAL GENERAL ANESTHESIA FOR ANOTHER PICC LINE INSERTION ON (B)(6) 2016 PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 6002674 ↗InjuryOct 6, 2016Fracture; Leak/Splash; Fracture; Leak/Splash
IT WAS REPORTED THAT A PICC LINE WAS INSERTED FOR 13 DAYS IN THE (B)(6) YEAR OLD FEMALE PATIENT TO ADMINISTER IV ANTIBIOTICS. HOWEVER, THE LINE FRACTURED AND WAS LEAKING AT THE JUNCTION BETWEEN THE HUB AND THE CLEAR FLEXIBLE TUBING. THE DOCTOR REPORTED THERE HAVE BEEN NO CHANGES IN CLINICAL PRACTICE WITH REGARDS TO CARE, MAINTENANCE OR INSERTION OF THE DEVICE. REPORTEDLY THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE TO INSERT A PERIPHERAL CANNULA TO COMPLETE AND EXTRA 7 DAYS OF IV ANTIBIOTIC THERAPY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 6002586 ↗MalfunctionOct 6, 2016Fracture; Leak/Splash; Fracture; Leak/Splash
IT WAS REPORTED THAT THE (B)(6) FEMALE PATIENT HAD A PICC LINE INSERTED FOR 11 DAYS TO ADMINISTER IV ANTIBIOTICS. THE LINE FRACTURED AND BEGAN LEAKING AT THE JUNCTION BETWEEN THE HUB AND THE CLEAR FLEXIBLE TUBING. THE DOCTOR REPORTED THERE HAVE BEEN NO CHANGES IN CLINICAL PRACTICE WITH REGARDS TO CARE, MAINTENANCE OR INSERTION OF THE DEVICE. REPORTEDLY THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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 6002539 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 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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