Cook G08376Recalls & reported problems
Cook Incorporated · Peripherally Inserted Central Venous Catheter Set Silicone · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002083769), received between May 26, 2016 and Nov 19, 2021 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (2 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 16, 2026.
Most reported problems
Device problems
- Unraveled Material2
- Crack1
- Difficult to Remove1
- Fluid/Blood Leak1
- Material Separation1
- Split1
Patient problems
- No Code Available3
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
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 12843850 ↗MalfunctionJun 5, 2020Unraveled Material; Unraveled Material
ADDITIONAL INFORMATION REGARDING THE EVENT WAS RECEIVED ON 16JUL2020. NO PART OF THE DEVICE WAS RETAINED BY THE PATIENT. THIS WAS CONFIRMED WITH AN X-RAY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10125118 ↗MalfunctionJul 24, 2019Unraveled Material; Unraveled Material
IT WAS REPORTED ON 19JUL2019 THAT THE COMPLAINT DEVICE WILL NOT BE RETURNED, AS THE FACILITY IS UNABLE TO LOCATE IT.
Patient problems: Pain
MAUDE report 8822075 ↗InjuryOct 6, 2016Split; Split
IT WAS REPORTED A PICC LINE WAS PLACED APPROXIMATELY 16 DAYS PRIOR TO THE EVENT DATE OF (B)(6) 2016 AT A DIFFERENT FACILITY. REPORTEDLY THERE WAS A SPIT IN THE LINE AND THE PATIENT HAD ANOTHER PICC LINE INSERTED WITHOUT ANY COMPLICATIONS.. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 6002701 ↗InjuryAug 9, 2016Difficult to Remove; Difficult to Remove
IT WAS REPORTED THE PEEL AWAY SHEATH FOR PERIPHERALLY INSERTED CENTRAL (PICC) LINE INSERTION BROKE WHEN ATTEMPTING TO PEEL IT AWAY. CONSEQUENTLY, THE SHEATH COULD NOT BE REMOVED. THIS WAS RECTIFIED BY HAVING A SECOND PERSON SCRUB INTO THE PROCEDURE AND UTILIZING ARTERY FORCEPS TO ATTACH TO THE SHEATH AND PEEL IT AWAY. 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 Code Available; No Known Impact Or Consequence To Patient
MAUDE report 5857677 ↗InjuryMay 26, 2016Material Separation; Material Separation
A (B)(6) FEMALE ONCOLOGY PATIENT REMOVED THE CATHETER HERSELF. THE TIP WAS NOT INTACT AT THE TIME OF REMOVAL. AT INSERTION, THE CATHETER WAS MEASURED AT 21CM, ONLY 2CM ATTACHED TO WINGS FOUND BY THE BEDSIDE NURSE. CHEST X-RAY DONE TO LOOK FOR THE RETAINED DEVICE, BUT THE CATHETER WAS NOT SEEN AT THE TIME OF THE X-RAY. LATER, THE REMAINING 19CM OF CATHETER WAS FOUND IN THE PATIENT'S BED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 5682343 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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