Cook Spectrum Turbo-Ject G34548Recalls & reported problems
Cook Incorporated · Cook Spectrum Turbo-Ject PICC Set Minocycline/Rifampin Impregnated Power Injectable Polyurethane Peripherally Inserted Central Venous Catheter · Class 2 · Implant
All models of Cook Spectrum Turbo-Ject (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Cook Spectrum Turbo-Ject PICC set is a long-term power-injectable central line coated with minocycline/rifampin antibiotic. The 37 reports mostly describe the catheter cracking, fracturing or splitting apart weeks after placement, along with leaking, and sometimes pieces coming loose, which required removing and replacing the line. No deaths were reported and 29 injuries were. No recalls name this device.
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
- 37
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00827002345485), received between Jan 19, 2017 and Dec 22, 2021 — classified as 29 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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
- Fluid/Blood Leak13
- Material Separation12
- Break6
- Crack5
- Fracture5
- Detachment of Device or Device Component4
- Fitting Problem4
- Leak/Splash4
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Code Available12
- Insufficient Information8
- No Known Impact Or Consequence To Patient7
- No Consequences Or Impact To Patient2
- Hematoma1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2021Crack; Fracture; Crack; Fracture
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 13064052 ↗InjuryAug 25, 2021Fluid/Blood Leak; Material Separation; Fitting Problem; Fluid/Blood Leak; Material Separation; Fitting Problem
IT WAS REPORTED A TURBO-JECT¿ SINGLE LUMEN MINOCYCLINE/RIFAMPIN POWER-INJECTABLE PICC BROKE 55 DAYS AFTER INITIAL PLACEMENT. THE PATIENT WAS RECEIVING AN MIVF INFUSION. WHEN FLUSHING THE MEDICATION, A CRACK WAS NOTICED ON THE PICC LINE. THE NEXT DAY THE DEVICE WAS REMOVED AND REPLACED WITH A SIMILAR DEVICE. POWER INJECTION WAS NOT USED. THE DEVICE WAS SECURED TO THE PATIENT WITH SUTURES, AN ADHESIVE BANDAGE AND K-LOC. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12367050 ↗InjuryAug 13, 2021Fracture; Material Separation; Fracture; Material Separation
THE FAILURE WAS NOTICED ONE MONTH AFTER DEVICE PLACEMENT. MIVF (MAINTENANCE INTRAVENOUS FLUID) INFUSION WAS BEING PERFORMED. THE DEVICE WAS NOT USED FOR POWER INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12319320 ↗InjuryAug 4, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IN ADDITIONAL INFORMATION RECEIVED ON 20AUG2021, IT WAS CONFIRMED THAT THE DEVICE FAILED AND WAS REMOVED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12274336 ↗InjuryJul 16, 2021Fluid/Blood Leak; Fracture; Material Separation; Fluid/Blood Leak; Fracture; Material Separation
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 12180360 ↗InjuryJul 14, 2021Break; Leak/Splash; Break; Leak/Splash
ADDITIONAL INFORMATION PROVIDED 25APR2022 INDICATED THE DEVICE BEGAN LEAKING / BREAKING AROUND 6 WEEKS POST INSERTION. THE DEVICE WAS SECURED TO THE PATIENT VIA STAT-LOCK AND TEGADERM. THE DEVICE REQUIRED REMOVAL AND REPLACEMENT. NO OTHER ADVERSE EFFECTS WERE REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12166901 ↗InjuryJul 14, 2021Fluid/Blood Leak; Fracture; Material Separation; Fluid/Blood Leak; Fracture; Material Separation
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12165460 ↗InjuryJul 9, 2021Partial Blockage; Leak/Splash; Partial Blockage; Leak/Splash
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12144081 ↗InjuryJun 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION PROVIDED ON 29JUN2021 STATED THE FAILURE WAS NOTED 6 DAYS AFTER PLACEMENT. THE DEVICE WAS SECURED WITH SUTURES AND AN ADHESIVE BANDAGE. THE DEVICE WAS BEING USED FOR BEDSIDE INFUSIONS, BUT POWER INJECTION WAS NOT USED. THE PATIENT REQUIRED A PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) LINE EXCHANGE WITH GENERAL ANESTHESIA FOLLOWING DISCONNECTION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12094875 ↗InjuryJun 24, 2021Fitting Problem; Detachment of Device or Device Component; Fitting Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ORANGE HUB OF A TURBO-JECT® DOUBLE LUMEN MINOCYCLINE/RIFAMPIN OVER-THE-WIRE POWER-INJECTABLE PICC PARTIALLY SEPARATED FROM THE EXTENSION TUBING. THE DEVICE WAS HEPARIN LOCKED. AS A RESULT OF THE SEPARATION, THE DEVICE WAS REMOVED AND REPLACED. THIS WAS REPORTED TO BE THE THIRD EXCHANGE FOR THIS PATIENT. GIVEN AVAILABLE PATIENT AND CUSTOMER INFORMATION, IT IS PRESUMED THAT THE PREVIOUS TWO EVENTS HAVE BEEN REPORTED UNDER MDR REF. #1820334-2021-01312 AND MDR REF. #1820334-2021-01507 (BOTH WITH PATIENT IDENTIFIER (B)(6)). ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12060078 ↗InjuryJun 24, 2021Fitting Problem; Detachment of Device or Device Component; Fitting Problem; Detachment of Device or Device Component
IN ADDITIONAL INFORMATION RECEIVED ON 10SEP2021, IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12059837 ↗InjuryJun 14, 2021Detachment of Device or Device Component; 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 Clinical Signs, Symptoms or Conditions
MAUDE report 11995479 ↗InjuryMay 10, 2021Material Separation; Fitting Problem; Material Separation; Fitting Problem
NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11801302 ↗InjuryApr 20, 2021Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 11696278 ↗MalfunctionApr 20, 2021Crack; Crack
IT WAS REPORTED THAT THE ORANGE HUB OF A TURBO-JECT® DOUBLE LUMEN MINOCYCLINE/RIFAMPIN OVER-THE-WIRE POWER-INJECTABLE PICC CRACKED. THE DEVICE WAS USED FOR INFUSIONS OF "NS CARRIER" AND MAINTENANCE INTRAVENOUS FLUID (MIVF). THE LINE ALSO "HAD PLATELETS" ON (B)(6)2021. THE DEVICE WAS LOCKED WITH HEPARIN PRIOR TO NOTICING THE CRACK "ON THE FLOOR" DURING THE NIGHT. THE DEVICE WAS REMOVED BUT NOT REPLACED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN CURRENTLY REPORTED. ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11696027 ↗InjuryApr 16, 2021Complete Blockage; Complete Blockage
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 11681135 ↗InjuryApr 16, 2021Complete Blockage; Complete Blockage
IN ADDITIONAL INFORMATION RECEIVED ON 21APR2021, IT WAS REPORTED THAT CATHETER MAINTENANCE PROTOCOL INCLUDED DRESSING CHANGES EVERY 7 DAYS, CAP CHANGES AND A HEPARIN LOCK WHEN NOT IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11680903 ↗InjuryAug 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
A MEDWATCH FORM WAS RECEIVED ON 26AUG2020. THE CUSTOMER REPORTED THEY HAVE HAD ISSUES WITH LEAKING AND AIR IN THE LINES OF DOUBLE LUMEN PICCS ON THREE SEPARATE OCCASIONS. THE THREE EVENTS ARE REPORTED IN MDR REPORT NUMBERS: 1820334-2020-01494, 1820334-2020-01496, AND 1820334-2020-01580 (SUBJECT OF THIS REPORT). THE LINES FOR EACH PATIENT HAD BEEN IN AT A MINIMUM OF 20 DAYS. THERE WERE NO DOCUMENTED ISSUES WITH ANY OF THE LINES IN THE 72 HOURS LEADING UP TO THE INCIDENTS. AFTER IDENTIFICATION OF THE CRACKED LINES, THE TEAM WAS NOTIFIED. ALL MEASURES WERE TAKEN (SWITCHING LUMENS, CLAMPING, PARAFILM) TO PROTECT THE PATIENTS FROM INFECTION AND AIR ENTRY. IT WAS REPORTED SOME OF THE LINES WERE PLACED IN THE GROIN AREA FOR 3 PATIENTS, AND ANOTHER INVOLVED A PATIENT'S RIGHT ARM. IT IS UNCLEAR AT THIS TIME WHICH DEVICES AND COMPLAINTS ARE ASSOCIATED WITH THE GROIN PLACEMENT SITE AND WHICH ARE ASSOCIATED WITH THE RIGHT ARM PLACEMENT SITE. CLARIFICATION WAS RECEIVED ON 16 SEP 2020 THAT THERE WAS NO 4TH INCIDENT. THE HUBS ON SOME OF THE LEAKING LINES WERE WHITE AND SOME WERE ORANGE. ALL 3 OF THE LINES HAD TO BE REPLACED, BUT NO ADDITIONAL HARM CAME TO ANY PATIENTS.
Patient problems: No Code Available
MAUDE report 10465510 ↗InjuryAug 14, 2020Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING 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 10408939 ↗InjuryAug 14, 2020Fluid/Blood Leak; Fluid/Blood Leak
A MEDWATCH FORM WAS RECEIVED ON 26AUG2020. THE CUSTOMER REPORTED THEY HAVE HAD ISSUES WITH LEAKING AND AIR IN THE LINE OF DOUBLE LUMEN PICC LINES ON THREE SEPARATE OCCASIONS. THE THREE EVENTS ARE REPORTED IN MDR REPORT NUMBERS: 1820334-2020-01494 (SUBJECT OF THIS REPORT), 1820334-2020-01496, AND 1820334-2020-01580. THE LINES FOR EACH PATIENT HAD BEEN IN AT A MINIMUM OF 20 DAYS. THERE WERE NO DOCUMENTED ISSUES WITH ANY OF THE LINES IN THE 72 HOURS LEADING UP TO THE INCIDENTS. AFTER IDENTIFICATION OF THE CRACKED LINES, THE TEAM WAS NOTIFIED. ALL MEASURES WERE TAKEN (SWITCHING LUMENS, CLAMPING, PARAFILM) TO PROTECT THE PATIENTS FROM INFECTION AND AIR ENTRY. IT WAS REPORTED SOME OF THE LINES WERE PLACED IN THE GROIN AREA FOR 3 PATIENTS, AND ANOTHER INVOLVED A PATIENT'S RIGHT ARM. IT IS UNCLEAR AT THIS TIME WHICH DEVICES AND COMPLAINTS ARE ASSOCIATED WITH THE GROIN PLACEMENT SITE AND WHICH ARE ASSOCIATED WITH THE RIGHT ARM PLACEMENT SITE. CLARIFICATION WAS RECEIVED ON 16SEP2020 THAT THERE WAS NO 4TH INCIDENT. THE HUBS ON SOME OF THE LEAKING LINES WERE WHITE AND SOME WERE ORANGE. ALL 3 OF THE LINES HAD TO BE REPLACED, BUT NO ADDITIONAL HARM CAME TO ANY PATIENTS.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10408028 ↗InjuryJul 16, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT A TURBO-JECT® DOUBLE LUMEN MINOCYCLINE/RIFAMPIN OVER-THE-WIRE POWER-INJECTABLE PICC BURST WHILE IMPLANTED IN THE PATIENT. THE DEVICE WAS INSERTED ON (B)(6) 2020 IN THE PATIENT'S LEFT BRACHIAL TO BE USED FOR TPN ADMINISTRATION. ON (B)(6) 2020, A HEMATOMA WAS NOTICED AT THE INSERTION SITE, PROMPTING REMOVAL OF THE DEVICE. UPON REMOVAL, THE DEVICE WAS NOTED TO BE "BURST AT THE 5SM MARK". A NEW DEVICE WAS IMPLANTED USING A DIFFERENT INSERTION SITE. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE DEVICE AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Hematoma; No Code Available
MAUDE report 10284801 ↗MalfunctionJun 1, 2020Break; Fluid/Blood Leak; Material Separation; Break; Fluid/Blood Leak; Material Separation
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10105484 ↗MalfunctionJun 1, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10105377 ↗MalfunctionJun 1, 2020Break; Fluid/Blood Leak; Material Separation; Break; Fluid/Blood Leak; Material Separation
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10105268 ↗MalfunctionJun 1, 2020Break; Fluid/Blood Leak; Material Separation; Break; Fluid/Blood Leak; Material Separation
IT WAS REPORTED THAT A TURBO-JECT DOUBLE LUMEN MINOCYCLINE/RIFAMPIN OVER-THE-WIRE POWER-INJECTABLE PICC BROKE AND THUS BEGAN TO LEAK AT THE JUNCTION BETWEEN THE WHITE HUB AND CATHETER LUMEN. THE DEVICE WAS IMPLANTED FOR 8 DAYS AND WAS BEING USED FOR ADMINISTRATION OF TPN AND LIPIDS. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10105116 ↗
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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.
How reports and recalls are matched · Editorial policy · Report an error on this page