Turbo-Ject G23905Recalls & 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
Quick summary
This Cook Medical Turbo-Ject PICC line is a long-term central venous catheter placed through the arm for IV fluids and contrast injection. The 39 reports mostly describe the line splitting, separating into two pieces, or developing holes and leaks, sometimes letting contrast leak under the skin, along with complete blockage and blood clots in the line. 26 injuries and no deaths were reported. No recalls name this device, and no reports came in the last 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
- 39
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00827002239050), received between Sep 25, 2015 and Jan 24, 2022 — classified as 26 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (5 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/Splash5
- Material Separation5
- Adverse Event Without Identified Device or Use Problem4
- Complete Blockage4
- Disconnection3
- Split3
- Break2
- Crack2
Patient problems
- No Code Available16
- No Known Impact Or Consequence To Patient8
- Thrombus5
- No Clinical Signs, Symptoms or Conditions4
- Thrombosis4
- No Consequences Or Impact To Patient3
- Foreign Body In Patient2
- Pain2
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjuryJan 24, 2022Material Rupture; Material Split, Cut or Torn; Material Rupture; Material Split, Cut or Torn
IT WAS REPORTED A TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC SPLIT DURING CONTRAST INJECTION. THE CONTRAST WAS INJECTED AT 5ML/S 300PSI. THE SPLIT WAS 1-1.5 CM UNDER THE SKIN AND RESULTED IN EXTRAVASATION OF CONTRAST. THE LINE WAS REMOVED AND REPLACED. NO OTHER ADVERSE EFFECTS WERE REPORTED.
Patient problems: Extravasation
MAUDE report 13337880 ↗InjuryOct 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12605063 ↗MalfunctionSep 10, 2021Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT A HOLE WAS FOUND IN A TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC DURING DEVICE INSERTION. DURING AN ATTEMPT TO FLUSH THE LINE, A HOLE WAS NOTICED. AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED WITHIN THE SAME PROCEDURE. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12453436 ↗InjuryJul 27, 2021Complete Blockage; Complete Blockage
IN ADDITIONAL INFORMATION RECEIVED ON 27JUL2021, IT WAS REPORTED THAT THE OBSTRUCTION IN THE PICC LINE WAS IDENTIFIED AFTER INSERTION, AS THE PICC WOULD NOT FLUSH IN ONE PORT. THE LINE WAS PLACED IN THE RIGHT CAVOATRIAL JUNCTION FOR THE ADMINISTRATION OF IV FLUIDS. IV ANTIBIOTICS, AND CT WITH CONTRAST. NO ADDITIONAL HARM TO THE PATIENT HAS BEEN REPORTED. UPON RETURN ON 09AUG2021, THE DEVICE WAS FOUND TO BE SEPARATED IN TWO PIECES AT THE WHITE CATHETER TUBING. THE PURPLE HUB WOULD NOT INITIALLY FLUSH BUT WAS ABLE TO AFTER IT WAS RINSED. THE WHITE HUB WAS ABLE TO BE FLUSHED WITH EFFORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12231990 ↗InjuryJun 10, 2021Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 11974235 ↗InjuryMay 11, 2021Material Separation; Material Separation
ADDITIONAL INFORMATION WAS PROVIDED 12MAY2021. IT WAS REPORTED WHEN THE LINE SEPARATED, THE NURSING STAFF CLAMPED THE LINE AND WRAPPED THE END IN SALINE SOAKED GAUZE. THE ON CALL PHYSICIAN WAS ALERTED AND ATTENDED IMMEDIATELY. THE PHYSICIAN NOTED THE DRESSING WAS INTACT AND SECURED WITH A "STATLOCK" DEVICE. THE REPORTED FAILURE CAUSED THE INTERRUPTION OF THE PATIENT'S TPN TREATMENT WHILE NEW LINE PLACEMENT WAS ARRANGED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11807859 ↗InjuryFeb 16, 2021Material Deformation; Material Deformation
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 11334309 ↗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 10844474 ↗InjuryAug 25, 2020Material Separation; Material Separation
IT WAS REPORTED THAT THE LINE OF A TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC SEPARATED FROM THE PURPLE HUB. FOLLOWING IMPLANTATION IN THE PATIENT'S ARM ON (B)(6) 2020, THE PATIENT LEFT THE HOSPITAL WITH A MICROCLAVE AND "LEAFLET AS PER IFU". THIS DEVICE WAS IMPLANTED TO SERVE AS A REPLACEMENT FOR A PREVIOUS DEVICE, WHICH IS ALSO REPORTED UNDER PATIENT IDENTIFIER (B)(6), MFG. REPORT REFERENCE #: 1820334-2020-01553. A DOUBLE LUMEN CATHETER WAS CHOSEN DUE TO UNAVAILABILITY OF THE SINGLE LUMEN CATHETER. LATER ON, THE PATIENT'S MOTHER REPORTED TO THE PHYSICIAN THAT THE "TONE SHAFT OF THE DOUBLE LUMEN CATHETER IS BROKEN". THE PATIENT'S MOTHER CLOSED THE BREAK WITH "LEUCOPLAST". THE DEVICE WAS REMOVED ON (B)(6) 2020 AND REPLACED. 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. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORT
Patient problems: No Code Available
MAUDE report 10449960 ↗InjuryMay 21, 2020Material Separation; Material Separation
IN ADDITIONAL INFORMATION RECEIVED ON 01JUN2020, IT WAS REPORTED BY THE RADIOGRAPHER WHO DID THE POWER INJECTION THAT IT WAS A VERY STANDARD CT WITH CONTRAST SCAN. THE PICC WAS FLUSHING WELL AND THE CONTRAST WENT IN WITH NO ISSUES (WELL BELOW THE MAXIMUM PSI/MLS PER SECOND AS INDICATED ON THE PICC LUMEN). THE SCAN WAS ABLE TO GET GOOD IMAGES. THE PICC WAS FLUSHED POST CONTRAST WITH NORMAL SALINE. THE LINE WASN'T NOTICED TO BE LEAKING UNTIL THE PATIENT RETURNED TO THE WARD. THE LEAK WAS FIRST OBSERVED BY WARD STAFF.
Patient problems: No Code Available
MAUDE report 10080157 ↗InjuryMay 19, 2020Material Rupture; Material Rupture
ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT WAS RECEIVED ON (B)(6) 2020. THE LINE WAS DRESSED ACCORDING TO THE USER FACILITY'S PROTOCOL USING OCCLUSIVE DRESSING. THE RUPTURE OCCURRED DOWNSTREAM OF A COMPETITOR SECURING DEVICE THAT WAS BEING USED TO SECURE THE LINE TO THE PATIENT. THE MAXIMUM ADMINISTRATION SETTING BEFORE POWER INJECTION WAS CHECKED BEFOREHAND AND REPORTED TO BE 3 ML/SEC WITH 250 PSI PRESSURE. THE LINE WAS LOCKED WITH SALINE WHEN NOT IN USE AND WAS MONITORED PER THE USER FACILITY'S PROTOCOL. THE PATIENT WAS REPORTED TO BE ACTIVE AND RECEIVING OUTPATIENT TREATMENT. THE PATIENT WAS MONITORED PER THE USER FACILITY'S PROTOCOL.
Patient problems: No Code Available; Pain; Swelling
MAUDE report 10070449 ↗InjuryMay 1, 2020Complete Blockage; Complete Blockage
IT WAS REPORTED THAT A TURBO-JECT SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC BECAME OCCLUDED AFTER IMPLANTATION. ONCE REMOVED, THE LINE WAS NOTED TO HAVE TWO KINKS. AS REPORTED, THE LINE WAS REMOVED BECAUSE IT WAS NO LONGER "TRANSPARENT" OR "FUNCTIONING" AND SEEMED TO BE BLOCKED. AFTER REMOVAL, THE NURSE NOTICED THAT THE LINE WAS KINKED IN TWO PLACES. A NEW LINE WAS PLACED WITH NO OTHER ADVERSE EFFECTS TO THE PATIENT. ADDITIONAL INFORMATION REGARDING THE DEVICE, PATIENT, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Code Available
MAUDE report 10017077 ↗MalfunctionMar 30, 2020Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9897354 ↗MalfunctionFeb 21, 2020Crack; Crack
ADDITIONAL INFORMATION WAS RECEIVED ON 09MAR2020. THE DEVICE WAS REMOVED FROM THE PATIENT AND DISCARDED.
Patient problems: No Code Available
MAUDE report 9739102 ↗MalfunctionJan 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9638153 ↗MalfunctionDec 4, 2019Unraveled Material; Unraveled Material
ADDITIONAL INFORMATION WAS RECEIVED ON 15JAN2020 STATING THAT THE WIRE COULD NOT BE REMOVED FROM THE PATIENT AS THE TIP OF IT WAS IN THE PATIENT'S VESSEL AND THE SECTION THAT HAD STARTED TO FRAY WAS STUCK IN THE PATIENT'S ARM FAT. IN ORDER TO REMOVE IT, THE PEEL-AWAY SHEATH WAS PLACED OVER THE WIRE AND IT WAS COMPLETELY REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9410718 ↗MalfunctionNov 22, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION REGARDING PATIENT/EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Pain
MAUDE report 9363965 ↗InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT.
Patient problems: Thrombosis; Thrombus
MAUDE report 8202755 ↗InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THEY RECEIVED AN ANECDOTAL REPORT OF THROMBUS FORMATION AROUND THE PICC LINES FOR SEVEN DIFFERENT PATIENTS. THIS RESULTED IN DEEP VEIN THROMBOSIS (DVT). ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. THE CUSTOMER HAS ADVISED THEY ARE SEEKING THE DETAILS OF THESE REPORTS. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN FORTHCOMING. THE FOLLOWING REPORTS ARE BEING FILED TO REPRESENT EACH OF THE INDICATED SEVEN PATIENTS. PATIENT 1, MANUFACTURER REPORT # 1820334-2018-03696. PATIENT 2, MANUFACTURER REPORT # 1820334-2018-03697. PATIENT 3, MANUFACTURER REPORT # 1820334-2018-03698. PATIENT 4, MANUFACTURER REPORT # 1820334-2018-03699. PATIENT 5, MANUFACTURER REPORT # 1820334-2018-03700. PATIENT 6, MANUFACTURER REPORT # 1820334-2018-03701. PATIENT 7, MANUFACTURER REPORT # 1820334-2018-03702.
Patient problems: Thrombosis; Thrombus
MAUDE report 8184936 ↗InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THEY RECEIVED AN ANECDOTAL REPORT OF THROMBUS FORMATION AROUND THE PICC LINES FOR SEVEN DIFFERENT PATIENTS. THIS RESULTED IN DEEP VEIN THROMBOSIS (DVT). ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. THE CUSTOMER HAS ADVISED THEY ARE SEEKING THE DETAILS OF THESE REPORTS. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN FORTHCOMING. THE FOLLOWING REPORTS ARE BEING FILED TO REPRESENT EACH OF THE INDICATED SEVEN PATIENTS. PATIENT 1, MANUFACTURER REPORT # 1820334-2018-03696. PATIENT 2, MANUFACTURER REPORT # 1820334-2018-03697. PATIENT 3, MANUFACTURER REPORT # 1820334-2018-03698. PATIENT 4, MANUFACTURER REPORT # 1820334-2018-03699. PATIENT 5, MANUFACTURER REPORT # 1820334-2018-03700. PATIENT 6, MANUFACTURER REPORT # 1820334-2018-03701. PATIENT 7, MANUFACTURER REPORT # 1820334-2018-03702.
Patient problems: Thrombosis; Thrombus
MAUDE report 8184932 ↗InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THEY RECEIVED AN ANECDOTAL REPORT OF THROMBUS FORMATION AROUND THE PICC LINES FOR SEVEN DIFFERENT PATIENTS. THIS RESULTED IN DEEP VEIN THROMBOSIS (DVT). ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. THE CUSTOMER HAS ADVISED THEY ARE SEEKING THE DETAILS OF THESE REPORTS. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN FORTHCOMING. THE FOLLOWING REPORTS ARE BEING FILED TO REPRESENT EACH OF THE INDICATED SEVEN PATIENTS. PATIENT 1, MANUFACTURER REPORT # 1820334-2018-03696, PATIENT 2, MANUFACTURER REPORT # 1820334-2018-03697, PATIENT 3, MANUFACTURER REPORT # 1820334-2018-03698, PATIENT 4, THIS MANUFACTURER REPORT #, PATIENT 5, MANUFACTURER REPORT # 1820334-2018-03700, PATIENT 6, MANUFACTURER REPORT # 1820334-2018-03701, PATIENT 7, MANUFACTURER REPORT # 1820334-2018-03702.
Patient problems: Thrombosis; Thrombus
MAUDE report 8184823 ↗MalfunctionMay 7, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED A TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC WAS LEAKING AT THE PURPLE HUB DUE TO A CRACK. TO DATE, ADDITIONAL INFORMATION REGARDING THE PATIENT AND EVENT HAVE NOT BEEN MADE AVAILABLE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THIS MEDWATCH REPORT IS ASSOCIATED WITH MEDWATCH 1820334-2018-01382 AS TWO DEVICE ISSUES OCCURRED WITH THE SAME PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7489861 ↗InjuryMay 7, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED A LEAK WAS FOUND ON A TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC AT THE PROXIMAL TIP AFTER CONNECTION TO THE PUMP. A NEW PICC LINE WAS NECESSARY; THEREFORE, IMPLANTATION OF THE NEW LINE WAS COMPLETED WHICH RESULTED IN AN EXTENSION OF THEIR HOSPITAL STAY.
Patient problems: No Code Available
MAUDE report 7489799 ↗InjuryMay 7, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED A LEAK WAS FOUND ON A TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC AT THE PROXIMAL TIP AFTER CONNECTION TO THE PUMP. A NEW PICC LINE WAS NECESSARY; THEREFORE, IMPLANTATION OF THE NEW LINE WAS COMPLETED WHICH RESULTED IN AN EXTENSION OF THEIR HOSPITAL STAY.
Patient problems: No Code Available
MAUDE report 7489797 ↗InjuryMay 4, 2018Complete Blockage; Complete Blockage
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
- Groshong NXT ClearVue Catheter 7617405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,708 reports
- Groshong NXT ClearVue Catheter 7655405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,536 reports
- PowerPICC Catheter 3174118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall402 reports
- L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cmArgon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days2 recalls245 reports
- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
- PowerPICC® Catheters 1174108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall222 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page