Cook Spectrum Turbo-Ject G23707Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002237070), received between Aug 9, 2017 and Nov 12, 2021 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2021Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  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 12807031 ↗
• InjuryApr 22, 2019Fracture; Fracture

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT.

  Patient problems: No Code Available

  MAUDE report 8535358 ↗
• InjuryNov 26, 2018Material Separation; Material Separation

  IT WAS REPORTED A SPECTRUM TURBO-JECT SINGLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC INSERTED ON (B)(6) 2018 WAS FOUND CRACKED AT THE EXTENSION TUBING ON (B)(6) 2018. THE DEVICE WAS REMOVED ON (B)(6) 2018 AND REPLACED WITH A NEW LINE USING THE SAME VESSEL. THE PATIENT WAS RECEIVING INFUSIONS AND VARIOUS MEDICAL TREATMENTS THROUGH THE LINE. TO DATE, ADDITIONAL PATIENT, EVENT AND DEVICE INFORMATION HAS 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 8101823 ↗
• InjuryJul 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A SPECTRUM TURBO-JECT SINGLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE WAS PLACED ON (B)(6) 2018 WITHOUT INCIDENT AND OPTIMAL TIP AT THE CAVOARTRIAL JUNCTION (CAJ) TO DELIVER CHEMOTHERAPY. THREE DAYS AFTER INSERTION, THE PATIENT PRESENTED WITH VENOUS THROMBOEMBOLISM (VTE) CONFIRMED THROUGH ULTRASOUND. AS REPORTED, THE RIGHT BASILIC WAS 4.4MM WHICH SHOULD HAVE BEEN SUFFICIENT FOR A 3FR PICC LINE. PER FACILITY PROTOCOL, THE LINES ARE FLUSHED TWICE PER DAY WITH HEPARIN. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE ON (B)(6) 2018 TO REMOVE AND REPLACE THE ORIGINAL PICC LINE. THE PATIENT RECEIVED LOVENOX (ENOXAPARIN SODIUM) INJECTION TO TREAT THE VTE.

  Patient problems: Thromboembolism

  MAUDE report 7713512 ↗
• InjurySep 13, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SPECTRUM TURBO-JECT SINGLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WAS NOTED TO BE LEAKING AT THE HUB AREA. PRIOR TO REMOVAL, THE HUB EVENTUALLY SEPARATED COMPLETELY FROM THE REST OF THE PICC LINE. THE DEVICE WAS INSERTED FOR SINGLE INDICATION OF CONTINUOUS TREPROSTINIL INFUSION. THE CUSTOMER ELABORATED: "PARTIAL HUB SEPARATION WAS NOTED AND THE DEVICE LIKELY ONLY HANDLED EVERY 96 HOURS FOR TUBING CHANGE." ULTIMATELY, THE PICC LINE WAS REMOVED AND REPLACED WITH ANOTHER PICC LINE. THE PRODUCT IS REPORTEDLY NOT AVAILABLE FOR RETURN.

  Patient problems: No Code Available

  MAUDE report 6862051 ↗
• InjurySep 13, 2017Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SPECTRUM TURBO-JECT SINGLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WAS NOTED TO BE LEAKING FROM A CRACK IN THE HUB AREA. THE DEVICE WAS INSERTED FOR SINGLE INDICATION OF CONTINUOUS TREPROSTINIL INFUSION. THE CUSTOMER ELABORATED: "PARTIAL HUB SEPARATION WAS NOTED AND THE DEVICE LIKELY ONLY HANDLED EVERY 96 HOURS FOR TUBING CHANGE." THE DEVICE WAS REPORTEDLY INSERTED FOR 136 DAYS PRIOR TO FAILURE. ULTIMATELY, THE PICC LINE WAS REMOVED AND REPLACED WITH ANOTHER PICC LINE. THE PRODUCT IS REPORTEDLY NOT AVAILABLE FOR RETURN.

  Patient problems: No Code Available

  MAUDE report 6862012 ↗
• InjurySep 12, 2017Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SPECTRUM TURBO-JECT SINGLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WAS NOTED TO BE LEAKING FROM THE HUB AREA. THE DEVICE WAS INSERTED FOR SINGLE INDICATION OF CONTINUOUS MILRINONE INFUSION. THE CUSTOMER ELABORATED: "PARTIAL HUB SEPARATION WAS NOTED AND ONLY HANDLED FOR EVERY 96 HOURS FOR TUBING CHANGES." ULTIMATELY, THE PICC LINE WAS REMOVED AND DREPLACED WITH ANOTHER PICC LINE. THE PRODUCT IS REPORTEDLY NOT AVAILABLE FOR RETURN.

  Patient problems: No Code Available

  MAUDE report 6857708 ↗
• InjuryAug 9, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED THAT A PATIENT HAD A SPECTRUM TURBO-JECT SINGLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC IMPLANTED ON (B)(6) 2017 FOR AN UNSPECIFIED INDICATION. THE CUSTOMER REPORTED THAT THE HUB DETACHED FROM THE DEVICE ON (B)(6) 2017. THE CIRCUMSTANCES AND HANDLING CONDITIONS FROM THE TIME OF IMPLANT TO THE TIME OF EVENT ARE NOT KNOWN. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6777418 ↗