Cook Spectrum Turbo-Ject G34554Recalls & 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
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002345546), received between Sep 29, 2016 and Sep 29, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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 18, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2016Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE PICC LINE BURST DISTALLY DURING FLUSHING. THE PATIENT WAS TAKEN TO THE INTERVENTIONAL RADIOLOGY (IR) DEPARTMENT AND THE FRAGMENTED PORTION WAS RETRIEVED WITH A SNARE. THERE WAS NO HARM TO THE PATIENT AND POST PROCEDURE THE PATIENT IS DOING "OKAY."
Patient problems: No Code Available
MAUDE report 5986412 ↗
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- 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
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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.
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