Turbo-Ject G34521Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00827002345218), received between Jun 14, 2016 and Oct 18, 2019 — classified as 11 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2019Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Occlusion

  MAUDE report 9210023 ↗
• 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 8184820 ↗
• InjuryAug 2, 2018Material Separation; Material Separation

  IT WAS REPORTED WHILE PLACING A TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC LINE IN THE LEFT ARM, THE GUIDE SLID INTO THE PATIENT'S FLESH RATHER THAN THE INTENDED VEIN. THIS RESULTED IN A SMALL PIECE OF METAL REMAINING IN SITU, BRUISING AT THE SITE OF PLACEMENT AND A FOLLOW-UP APPOINTMENT SCHEDULED FOR MONITORING. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT HAS BEEN REQUESTED BUT NOT YET PROVIDED. AS REPORTED, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7743095 ↗
• InjuryApr 26, 2018Partial Blockage; Partial Blockage

  IT WAS REPORTED A TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC BECAME BLOCKED A DAY AFTER PLACEMENT. THE LINE WAS PULLED BACK 1 CM AND FLUSHED SUCCESSFULLY. HOURS LATER, THE LINE BECAME BLOCKED AGAIN AND WAS UNSUCCESSFULLY FLUSHED. THE PICC WAS REMOVED AND REPLACED THE FOLLOWING DAY WITH A NEW DEVICE. AS REPORTED, THE REPLACEMENT PROCEDURE WAS DIFFICULT DUE TO CHALLENGING VEIN ACCESS, WHICH LEFT THE PATIENT WITH MULTIPLE BRUISES. THE ORIGINAL LINE WAS VISUALLY INSPECTED AND FOUND TO HAVE TWO KINKS, ONE AT 9.5 CM AND ONE AT 12 CM.

  Patient problems: No Code Available

  MAUDE report 7464062 ↗
• InjuryFeb 20, 2018Kinked; Kinked

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE PATIENT'S TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) AFTER ONE WEEK IMPLANTATION INTO THE RIGHT BASILIC VEIN, THE PICC LINE WAS DIFFICULT TO FLUSH. THE PATIENT'S CHEMOTHERAPY TREATMENTS WERE SUPPOSED TO INFUSE OVER 48 HOURS, BUT THEY TOOK 72 HOURS TO INFUSE. INCREASED DIFFICULTY WITH FLUSHING THE LINE WAS REPORTED AND THE INFUSION RATE CONTINUED TO WORSEN OVER TIME. THERE WAS AN EXTERNAL KINK IN THE LINE NOTED, AND ONCE THE PATIENT'S DRESSINGS WERE TAKEN DOWN AND THEIR SECURACATH WAS REMOVED, THE LINE WAS EVEN MORE DIFFICULT TO FLUSH. THE PATIENT HAD THE PICC LINE IMPLANTED FOR ABOUT A MONTH. AS A RESULT OF THE ISSUES EXPERIENCED, THE DEVICE WAS REMOVED FROM THE PATIENT AND NEW PICC LINE PLACED. ONCE THE LINE WAS REMOVED, MULTIPLE KINKS IN THE LINE WHICH HAD BEEN INTERNAL TO THE PATIENT WERE VISIBLE. ONCE THE DEVICE WAS REMOVED IT FLUSHED EASILY. THE 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 7284873 ↗
• MalfunctionSep 20, 2017Device Operates Differently Than Expected

  WHILE ATTEMPTING TO PEEL AWAY THE INTRODUCER SHEATH, THE ORANGE/YELLOW 'WING' SNAPPED OFF ON ONE SIDE. AN ARTERY FORCEP WAS THEN USED TO COMPLETE THE PEEL AWAY ACTION. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6880808 ↗
• MalfunctionSep 18, 2017Detachment Of Device Component

  VASCULAR ACCESS INSERTION NURSE HAS REPORTED THAT THE PICC CATHETER HAS BECOME DISJOINED FROM THE HUB. PICC LINE WAS REMOVED. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE EVENT. NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873353 ↗
• MalfunctionSep 18, 2017Material Too Rigid or Stiff; Sticking

  THE BASE OF THE DILATOR OF THE INTRODUCER DID NOT ALLOW THE FLEXIBLE AND CURVED PORTION OF THE GUIDES TO GO THROUGH. THE WIRE GUIDE WAS STUCK/ BLOCKED INSIDE THE PEEL AWAY INTRODUCER AND THE RADIOLOGIST HAD TO PULL OUT IN FORCE ON THE PEEL AWAY TO EXTRACT IT WITH THE WIRE GUIDE INSIDE. ONLY THE STIFF PART (BACKWARDS GUIDE) PASSED THROUGH AFTER MULTIPLE TRIES AND THE REPORTER NOTED A RISK OF A PARIETAL LESION. THERE WAS "A LOT" OF BLEEDING. THIS PRODUCT PROBLEM OCCURRED MORE THAN ONCE WITH THE 4FR (FRENCH) OTW PICC LINES. THE RADIOLOGISTS DECIDED TO SWITCH TO THE 5FR PICC LINES AS A RESULT, BUT IT WAS NOTED THAT CHANGING THE SIZE POSED A RISK OF THROMBOSIS TO THE PATIENT. THE PATIENT REQUIRED A NEW PICC LINE INSERTION AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6871823 ↗
• InjurySep 15, 2017Defective Component

  IT WAS REPORTED THE CUSTOMER ALLEGES THERE IS A DEFECT (UNSPECIFIED) IN THE PICC LINE. ACCORDING TO THE CUSTOMER, THE EVENT LED TO AN ADDITIONAL PROCEDURE TO REMOVE AND REPLACE THE PICC LINE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Code Available

  MAUDE report 6868259 ↗
• InjuryJul 28, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT RECEIVED A TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC FOR AN UNSPECIFIED INDICATION. THE DATE OF IMPLANT IS NOT KNOWN. THE CUSTOMER REPORTED THAT THE DEVICE BROKE AT THE JUNCTION OF THE CATHETER AND THE HUB. THE CIRCUMSTANCES AND HANDLING CONDITIONS AT THE TIME OF EVENT ARE NOT KNOWN. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR EXPLANT OF THE BROKEN DEVICE AND REPLACEMENT WITH A NEW DEVICE. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6751025 ↗
• InjuryJul 12, 2017Unraveled Material; Unraveled Material

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC. THE WIRE GUIDE BECAME STUCK AS THE PHYSICIAN ATTEMPTED TO PUSH THE GUIDE THROUGH THE VENIPUNCTURE NEEDLE. THE NEEDLE WAS REMOVED TO AID IN THE UNSUCCESSFUL REMOVAL OF THE GUIDE WIRE. THE PUNCTURE SITE WAS 'GENTLY' ENLARGED WITH A SCALPEL. THE WIRE WAS SUCCESSFULLY REMOVED AFTER APPROXIMATELY 10 MINUTES OF MINOR MANIPULATION. A NEW CATHETER COULD NOT BE PLACED BECAUSE THE PATIENTS' VESSELS COLLAPSED. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS ANTICIPATED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6705357 ↗
• InjuryJun 1, 2017Leak/Splash; Leak/Splash

  CUSTOMER REPORTED THAT A TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC WAS IMPLANTED ON AN UNSPECIFIED DATE FOR INFUSING ANTIBIOTICS UNTIL (B)(6) 2017. THE SPECIFIC ANTIBIOTIC WAS NOT IDENTIFIED. THE CUSTOMER REPORTS THAT THE DEVICE BEGAN TO LEAK AT THE CONNECTION WHERE THE TUBING ENTERS THE MANIFOLD. THE PATIENT UNDERWENT EXPLANT OF THE LEAKING DEVICE AND REPLACEMENT WITH A NEW CATHETER. NO UNINTENDED PORTION OF THE DEVICE REMAINED WITHIN THE PATIENT. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6604786 ↗
• InjuryFeb 15, 2017Leak/Splash; Leak/Splash

  CUSTOMER REPORTED THAT A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS PLACED ON (B)(6) 2016 FOR AN UNSPECIFIED INDICATION. THE LINE LEAKED AT THE HUB THREE MONTHS FOLLOWING INITIAL IMPLANT. THE DEVICE WAS COMPLETELY EXPLANTED AND REPLACED. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6332266 ↗
• InjuryJan 19, 2017Unraveled Material; Unraveled Material

  INTERNATIONAL CUSTOMER REPORTED THAT THE WIRE BECAME CAUGHT ON THE LUMEN OF A PEEL AWAY SHEATH DURING A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE PLACEMENT. THE WIRE SUBSEQUENTLY UNCOILED/ UNRAVELED. AN ADDITIONAL UNSPECIFIED PROCEDURE WAS ALLEGEDLY REQUIRED TO ADDRESS THIS EVENT. NO FURTHER EVENT OR PATIENT DETAILS WERE PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6263084 ↗
• MalfunctionNov 21, 2016Material Separation; Material Separation

  IT WAS REPORTED AFTER SUCCESSFULLY INSERTING THE PICC, THE USER WAS IN THE PROCESS OF PEELING AWAY THE SHEATH BUT FOUND IT VERY DIFFICULT TO SPLIT THEN AS SHE WAS PEELING IT, THE LEFT YELLOW "HANDLE" PIECE COMPLETELY SEPARATED FROM THE GREY SHEATH .A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 6117826 ↗
• MalfunctionOct 13, 2016Fracture; Leak/Splash; Fracture; Leak/Splash

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT WITH A HISTORY OF SPINAL INJURY WAS BEING TREATED FOR PRESSURE ULCERS. A PICC LINE WAS BEING USED TO ADMINISTER ANTIBIOTICS. THE VASCULAR ACCESS INSERTION NURSE REPORTED THAT THE PICC CATHETER WAS "FRACTURED" AND LEAKING AT THE JOINT OF THE HUB AND THE CLEAR PLASTIC FLEXIBLE TUBING. THE DWELLING TIME OF THE MANUFACTURER'S CATHETER WAS 7 DAYS. AS THE PATIENT REQUIRED 6 WEEKS OF TREATMENT, THE PICC LINE WAS REPLACED WITH A COMPETITOR'S PRODUCT SO THAT THE PATIENT COULD CONTINUE TREATMENT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6026810 ↗
• InjuryAug 9, 2016Split; Split

  IT WAS REPORTED BY THE VASCULAR ACCESS INSERTION NURSE THAT THE MOST PROXIMAL END OF THE CLEAR PLASTIC, JUST BELOW THE MAIN HUB ON THE PERIPHERALLY INSERTED CENTRAL CATHETERS (PICC), HAS CRACKED. THE PICC LINE BEING USED FOR ANTIBIOTIC THERAPY WAS REMOVED AND THE PATIENT COMMENCED ORAL ANTIBIOTICS. REPORTEDLY THE PATIENT CONDITION DETERIORATED AND NEEDED A NEW PICC LINE INSERTED. THE INITIAL PICC DWELLING TIME WAS 59 DAYS. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE - AN NEW PIC CLINE WAS INSERTED. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5856109 ↗
• MalfunctionJun 14, 2016Crack; Crack

  VASCULAR ACCESS INSERTION NURSE HAS REPORTED THAT THE PICC CATHETER WAS LEAKING AT THE JUNCTION BETWEEN THE PURPLE HUB AND THE CLEAR FLEXIBLE TUBING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5723439 ↗