Turbo-Ject G56194Recalls & 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 18, 2026 from official FDA records · Editorial policy
Quick summary
This Cook Turbo-Ject power injectable PICC set is a long-term central venous catheter used for chemotherapy and other infusions. The 38 reports mostly describe the catheter tearing, cracking or splitting during or after placement, leaking, sticking, and being hard to remove, with guide wires and lumens breaking or getting stuck inside patients. Fifteen reports involved injuries and none involved deaths. No recalls name this device, and no reports were filed in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00827002561946), received between May 17, 2016 and Mar 3, 2022 — classified as 15 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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 18, 2026.
Most reported problems
Device problems
- Material Separation6
- Break5
- Leak/Splash5
- Difficult to Remove3
- Fluid/Blood Leak3
- Split3
- Sticking3
- Crack2
Patient problems
- No Known Impact Or Consequence To Patient17
- No Code Available14
- No Consequences Or Impact To Patient6
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2022Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn
IT WAS REPORTED THAT A TURBO-JECT POWER INJECTABLE CENTRAL VENOUS CATHETER BECAME TORN DURING A PICC LINE PLACEMENT PROCEDURE ON AN UNKNOWN PATIENT. ANOTHER LIKE DEVICE WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE DEFECTIVE PRODUCT WAS IMMEDIATELY DISCARDED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13660829 ↗InjuryJun 30, 2020Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 10213291 ↗InjuryMay 13, 2020Fitting Problem; Fitting Problem
IT WAS REPORTED THAT THE HUB OF A TURBO-JECT POWER INJECTABLE PICC SPLIT FROM THE EXTENSION TUBING. THE SPLIT WAS NOTICED POST INSERTION OF THE PICC LINE IN MEDICAL IMAGING, AND THE EXTENSION TUBING WAS NOTED TO BE COMPLETELY DISCONNECTED FROM THE "PURPLE DISTAL LUMEN". THE PICC LINE WAS SUBSEQUENTLY REMOVED AND REPLACED. THE CATHETER WAS PLACED IN THE LEFT BASILIC VEIN AND THE INDICATION FOR PLACEMENT WAS FOR CHEMOTHERAPY TREATMENT. IT WAS REPORTED THAT OTHER "POTENTIAL INFUSIONS" WERE ALSO USED WITH THE CATHETER. THE CATHETER FAILED DURING TREATMENT. IT IS NOT KNOWN HOW LONG THE CATHETER WAS IN PLACE OR WHAT PROCEDURE WAS BEING PERFORMED AT THE TIME OF FAILURE. THE CATHETER WAS NOT BEING USED WITH OTHER DEVICES. THE CATHETER WAS SECURED TO THE PATIENT USING A STAT LOCK AND THE PATIENT'S ACTIVITY LEVEL WAS UNKNOWN. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED.
Patient problems: No Code Available
MAUDE report 10051666 ↗MalfunctionMar 19, 2020Complete Blockage; Complete Blockage
NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9856575 ↗InjuryMar 16, 2020Break; Break
IT WAS REPORTED THAT ONE OF THE LUMENS OF A DOUBLE LUMEN TURBO-JECT POWER INJECTABLE DEVICE BROKE DURING USE. NO ADVERSE EFFECTS HAVE BEEN REPORTED.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 9834935 ↗InjurySep 17, 2019Material Fragmentation; Material Fragmentation
NO ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING PATIENT AND/OR EVENT DETAILS SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 9076026 ↗MalfunctionJan 21, 2019Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material
IT WAS REPORTED THE GUIDE WIRE FOR INSERTION OF A TURBO-JECT POWER INJECTABLE URETHANE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) BECAME LODGED IN THE PATIENT'S BASILIC VEIN. AS A RESULT, A DILATOR WAS INSERTED OVER THE WIRE TO EFFECTIVELY FREE THE WIRE FROM THE VEIN AND NO HARM WAS REPORTED TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT DID NOT HAVE TORTUOUS ANATOMY AND A SECOND DEVICE WAS NOT USED FOR COMPLETION OF THE PROCEDURE. UPON INSPECTION OF THE GUIDE WIRE BY THE MANUFACTURER, IT WAS DISCOVERED THE DISTAL PORTION OF THE DEVICE WAS UNRAVELED AND ELONGATED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8265128 ↗MalfunctionDec 12, 2018Blocked Connection; Blocked Connection
IT WAS ORIGINALLY REPORTED THAT A TURBO-JECT POWER INJECTABLE PICC LINE PLACED ON (B)(6) 2018 WAS FOUND TO BE BLOCKED ON (B)(6) 2018 . IN A CORRECTION TO THE ORIGINAL DESCRIPTION, THE PICC LINE BLOCKAGE WAS FOUND ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8156296 ↗InjuryNov 21, 2018Material Separation; Material Separation
IT WAS REPORTED A TURBO-JECT POWER INJECTABLE PICC LINE TUBING SEPARATED AT THE VALVE. THE LINE WAS CLAMPED, SOAKED WITH BETADINE, COVERED WITH A STERILE COMPRESS AND WRAPPED. THE DEVICE WAS REMOVED AND REPLACED IN A SECOND PROCEDURE THREE DAYS AFTER THE SEPARATION WAS IDENTIFIED. TO DATE, ADDITIONAL INFORMATION REGARDING THE PATIENT, EVENT AND DEVICE HAVE BEEN REQUESTED BUT NOT YET PROVIDED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 8097884 ↗MalfunctionJul 3, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THE WIRE WOULD NOT PULL OUR OF THE CATHETER AFTER A TURBO-JECT POWER INJECTABLE PICC LINE WAS INSERTED. THE PATIENT WAS SAID TO HAVE ANGULATED AND TORTUOUS VESSELS. ANOTHER SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7659287 ↗MalfunctionJun 14, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED WHILE GUIDING THE WIRE TO THE TARGET VESSEL, THE TIP LODGED ITSELF IN A SMALL BRANCH. WHILE PULLING THE WIRE BACK, THE WIRE WAS FELT TO BE ELONGATING. AFTER THREE HOURS THE WIRE WAS RETRIEVED WITH A 5FR BRITE TIP SHEATH COAXIALLY WITH A 2.6FR CXI CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICES AND THEIR COMPONENTS WERE EXAMINED AFTER REMOVAL AND THE "SPRING-LIKE" WIRE TIP WAS VISUALLY CONFIRMED TO BE ELONGATED/UNWOUND. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7600332 ↗MalfunctionMar 6, 2018Crack; Crack
THE CUSTOMER INITIALLY REPORTED THAT, AS THE PEEL AWAY SHEATH OF THE TURBO-JECT POWER INJECTABLE WAS BEING INSERTED DURING A PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE INSERTION PROCEDURE, THE SHEATH BUCKLED, AND A NEW KIT NEEDED TO BE OPENED. NO PATIENT ADVERSE EVENTS WERE REPORTED, AND NO ADDITIONAL PROCEDURES WERE REQUIRED. THE MALFUNCTION RESULTED ONLY IN MINOR INCONVENIENCE. THE DEVICE WAS RETURNED FOR EVALUATION AND DURING THE PHYSICAL EXAMINATION OF THE RETURNED DEVICE, THE TIP OF THE CATHETER WAS DETERMINED TO BE BUCKLED AND TORN CREATING A SHARP EDGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7319571 ↗MalfunctionJan 11, 2018Mechanical Problem; Mechanical Problem
THE INTERNATIONAL CUSTOMER REPORTED THAT THE "LONG MEASURING WIRE" [SIC] BECAME STUCK IN THE TURBO-JECT POWER INJECTABLE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. ANOTHER WIRE WAS ULTIMATELY DEPLOYED IN AN ATTEMPT TO UN-STICK THE FIRST WIRE. EVENTUALLY, THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EVENTS, AND THE PICC LINE WAS FINALLY PLACED IN SITU AS INTENDED. THE WIRE WAS REPORTEDLY ONLY INSERTED FOR 3-5 SECONDS, AND THE PLACEMENT OF THE CATHETER WAS IN THE BASILICA VESSEL OF THE UPPER MIDDLE ARM OF THE PATIENT. THE WIRE WAS FLUSHED AND WELL LUBRICATED. THE PATIENT DID NOT HAVE ANY NOTABLE PRE-EXISTING CONDITIONS, AND THE DEVICE WAS UTILIZED IN A DECENTLY SIZED VESSEL, WITH NO VASCULAR COMPLICATIONS. THE PRODUCT 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 7182727 ↗MalfunctionDec 18, 2017Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem
THE INTERNATIONAL CUSTOMER REPORTED THAT THE TURBO-JECT POWER INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) COULD NOT BE PLACED IN THE PATIENT, DUE TO A FAULTY PURPLE HUB. THE PICC LINE WAS REPORTEDLY LEAKING IMMEDIATELY AT THE SITE OF THE HUB ON THE SIDE OF THE TRANSPARENT PORTION OF THE CATHETER. ANOTHER LINE HAD TO BE PLACED INSTEAD, BUT THE PLACEMENT OCCURRED IMMEDIATELY AFTER THE PROBLEM WAS DISCOVERED. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7126406 ↗MalfunctionNov 9, 2017Partial Blockage; Partial Blockage
THE INTERNATIONAL CUSTOMER REPORTED THAT THE WIRE INCLUDED IN THE TURBO-JECT POWER INJECTABLE PRODUCT BECAME STUCK IN THE PERIPHERALLY INSERTED CENTRAL CATHETER. THE OPERATOR HAVE TO PLACE ANOTHER WIRE IN THE OTHER LUMEN OF THE DEVICE TO UNSTICK THE FIRST WIRE. NO ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT OF THE ISSUE, AND NO PATIENT ADVERSE EVENTS OCCURRED DUE TO THE REPORTED PRODUCT PROBLEM. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7015324 ↗InjuryOct 10, 2017Break; Break
IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT, AT AN UNDISCLOSED POINT IN TIME FOLLOWING THE OPENING AND USE OF THE PRODUCT, "A RUPTURE OF THE GUIDE HAPPENED IN THE PICC" [SIC] (PERIPHERALLY INSERTED CENTRAL CATHETER). ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. THE LINE WAS CHANGED TO RESOLVE THE PRODUCT ISSUE. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO PRODUCT HAS YET BEEN RECEIVED FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 6935279 ↗InjurySep 26, 2017Split
THE LUMEN OF PICC HAD A SPLIT JUST BELOW THE HUB. THE PICC LINE HAD TO BE REMOVED, TREATMENT STOPPED AND THE PATIENT HAD TO BE SCHEDULED TO COME BACK IN FOR ANOTHER PICC LINE TO BE INSERTED.
Patient problems: No Code Available
MAUDE report 6893106 ↗MalfunctionSep 25, 2017Loose or Intermittent Connection
THE CUSTOMER REPORTED THAT WHEN PEELING OFF THE TOP PART OF THE INTRODUCER, IT BECAME LOOSE FROM THE DEVICE. NO PART OF THE DEVICE WAS LEFT IN THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6890345 ↗InjurySep 18, 2017Leak/Splash
THE CUSTOMER REPORTED THAT THE PICC LINE HAD A LEAK IN THE EXTENSION TUBE DURING A RED CELL INFUSION, THOUGH THEY WERE NOT SURE IF THE LEAK WAS AT THE WHITE OR PURPLE LUMEN. THE DEVICE WAS REPLACED, BUT THERE WERE NO INJURIES ASIDE FROM THIS REPLACEMENT PROCEDURE.
Patient problems: No Code Available
MAUDE report 6874207 ↗MalfunctionSep 18, 2017Break; Detachment Of Device Component
IT WAS REPORTED "THE YELLOW TIP (PULL-AWAY WING) OF THE INTRODUCER BROKE AND WAS SEPARATED WHEN THE PHYSICIAN WANTED TO OPEN THE PEEL-AWAY. THE GREY PARTS (SHEATH SHAFT) WERE ALREADY IN THE PATIENT, SO HE HAD TO REMOVE IT VERY CAREFULLY. IT COULD STAY INSIDE THE VEIN...".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6872495 ↗InjurySep 18, 2017Break; Material Separation
THE YELLOW TIP OF THE INTRODUCER BROKE AND WAS SEPARATED WHEN THE PHYSICIAN PEELED AWAY THE SHEATH. PARTS OF THE DEVICE WERE ALREADY IN THE PATIENT, SO HE HAD TO REMOVE IT VERY CAREFULLY. THE PIECES WERE RETRIEVED. 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 Code Available
MAUDE report 6872206 ↗InjurySep 15, 2017Leak/Splash
PICC WAS INSERTED WITHOUT DIFFICULTY THEN PATIENT RECEIVE FIRST TREATMENT OF CHEMO. PATIENT RETURNED FOR SECOND ROUND OF CHEMO AND THE STAFF SAW A LEAK AT CONNECTION BETWEEN THE HUB AND THE CLEAR PLASTIC TUBING OF THE LUMEN. THERE WERE NO ADDITIONAL PIECES OF EQUIPMENT ATTACHED TO THE PICC. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATENTS¿ BODY. THE PICC LINE WAS REPLACED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 6870208 ↗MalfunctionSep 15, 2017Entrapment of Device; Sticking
THE CUSTOMER REPORTED THAT DURING INSERTION OF THE PICC LINE, THE WIRE GUIDE BECAME STUCK IN THE CATHETER AND FORCE HAD TO BE USED BY THE DOCTOR IN ORDER TO EXTRACT THE WIRE GUIDE FROM THE PATIENT. THE REST OF THE PROCEDURE PROCEEDED WITHOUT INCIDENT AND THE PICC LINE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THERE WERE NO INJURIES AND NO ADDITIONAL PROCEDURES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6869041 ↗InjurySep 15, 2017Leak/Splash; Split
THE CUSTOMER REPORTED THAT WHILE THE PATIENT WAS UNDERGOING CYTARABINE INFUSION, THE PICC LINE WAS NOTICED TO BE LEAKING NEAR THE HUB. A SMALL SPILT IN THE LINE WAS DETECTED. THE DEVICE WAS REMOVED AND REPLACED. NO PIECES OF THE COMPLAINT DEVICE WERE LEFT IN THE PATIENT, AND THERE WERE NO FURTHER INJURIES ASIDE FROM THE ADDITIONAL PROCEDURE.
Patient problems: No Code Available
MAUDE report 6868901 ↗MalfunctionSep 15, 2017Difficult to Remove
THE CUSTOMER REPORTED THAT THEY WERE HAVING DIFFICULTIES PULLING THE WIRE THROUGH THE DOUBLE-LUMEN PICC LINE, EVEN AFTER FLUSHING. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6868783 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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