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Turbo-Ject G49173Recalls & 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

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002491731), received between Oct 17, 2017 and Mar 22, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

  • Break1
  • Collapse1
  • Material Disintegration1
  • Material Twisted/Bent1
  • Separation Problem1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • Foreign Body In Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 22, 2019Separation Problem; Separation Problem

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

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8445826 ↗
  • MalfunctionMay 11, 2018Collapse; Collapse

    IT WAS REPORTED THAT THE PHYSICIAN PUNCTURED THE VESSEL AND INSERTED THE SHEATH AS USUAL FOR A PICC INSERTION IN THE PATIENT'S RIGHT ARM. WHEN HE ATTEMPTED TO REMOVE THE DILATOR AND WIRE, HE FELT A LITTLE RESISTANCE AND FOUND THE WIRE HAD COLLAPSED. THE PHYSICIAN REMOVED THE WIRE SLOWLY AND CAREFULLY, AND CONFIRMED NO PARTS OF WIRE REMAINED IN THE PATIENT'S BODY, THEN CONTINUED WITH THE PROCEDURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7507243 ↗
  • InjuryOct 17, 2017Break; Material Disintegration; Material Twisted/Bent; Break; Material Disintegration; Material Twisted/Bent

    THE INTERNATIONAL CUSTOMER REPORTED THAT, A PIECE OF THE GUIDE WIRE CONTAINED IN THE TURBO-JECT OVER-THE-WIRE SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET BROKE OFF AND WAS RETAINED IN THE PATIENT. THE OPERATOR HAD INITIALLY ATTEMPTED TO INSERT THE DEVICE INTO THE PATIENT'S VESSEL WHEN RESISTANCE WAS ENCOUNTERED. THE OPERATOR ROTATED THE WIRE PER PROCEDURE IN AN ATTEMPT TO RELEASE THE RESISTANCE, AND WHEN THE RESISTANCE SUBSIDED, PROCEEDED TO PUSH THE WIRE FORWARD WITHOUT CONFIRMING THE LOCATION AND CONDITION OF THE WIRE VIA FLUOROSCOPY. WHEN THE WIRE HAD ALMOST REACHED THE PATIENT'S HEART, THE OPERATOR DID PERFORM A FLUOROSCOPIC CHECK OF THE WIRE, AT WHICH TIME THE WIRE TIP WAS OBSERVED TO BE TWISTED AND DISINTEGRATED. THE OPERATOR ATTEMPTED TO REMOVE ALL GUIDE WIRE FRAGMENTS, BUT A 2-3 CM FRAGMENT REMAINED IN THE PATIENT'S "RIGHT VENTRICULAR" [SIC]. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.

    Patient problems: Foreign Body In Patient

    MAUDE report 6954076 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

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Sources and updates

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