Peel-AwayRecalls & reported problems across all models
Cook Incorporated · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Peel-Away model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 1
We found 7 models of Peel-Away by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2014 and Aug 12, 2020 — classified as 4 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Collapse” (2 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Peel-Away recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 1, 2024Open, Classified
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1528-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported Peel-Away problems
Device problems
- Collapse2
- Material Frayed2
- Material Separation2
- Material Twisted/Bent2
- Stretched2
- Unraveled Material2
- Break1
- Crack1
Patient problems
- No Consequences Or Impact To Patient5
- No Code Available2
- No Known Impact Or Consequence To Patient2
- Foreign Body In Patient1
- No Patient Involvement1
- Nonresorbable materials, unretrieved in body1
Peel-Away models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Peel-Away G00925Tubes, gastrointestinal (and accessories)1 recall0 reports
- Peel-Away G01844Tubes, gastrointestinal (and accessories)1 recall0 reports
- Peel-Away G11564Tubes, gastrointestinal (and accessories)4 reports
- Peel-Away G11568Tubes, gastrointestinal (and accessories)4 reports
- Peel-Away G04096Tubes, gastrointestinal (and accessories)1 report
- Peel-Away G11559INTRODUCER, CATHETER1 report
- Peel-Away G11567Tubes, gastrointestinal (and accessories)1 report
Recent Peel-Away adverse event reports
The 11 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2020Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10398659 ↗MalfunctionAug 12, 2020Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10398548 ↗InjuryOct 7, 2019Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient
MAUDE report 9161764 ↗InjuryOct 1, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 9139726 ↗InjurySep 25, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 9116371 ↗MalfunctionNov 12, 2018Collapse; Material Frayed; Collapse; Material Frayed
IT WAS REPORTED A PEEL-AWAY DENNY SHEATH INTRODUCER SET WAS USED FOR PLACEMENT OF A PERIPHERALLY INSERTED CENTRAL CATHETER IN THE INNER PORTION OF THE UPPER ARM OF THE PATIENT (NO ANOMALIES/PREVIOUS SCARRING). THE PHYSICIAN ACCESSED THE VESSEL WITH ULTRASOUND GUIDANCE AND SUCCESSFULLY ADVANCED THE WIRE. UPON ATTEMPTING TO ADVANCE THE DENNY SHEATH, THE PRODUCT BUCKLED AND THE TIP OF THE SHEATH WAS FOUND TO HAVE FRAYED. THIS HAPPENED A TOTAL OF FIVE TIMES WITH DIFFERENT DENNY SHEATHS EACH TIME. A SIXTH DENNY SHEATH WAS USED SUCCESSFULLY AND ALTHOUGH PROLONGED, THE PROCEDURE WAS COMPLETED. THIS REPORT RECORDS TWO OF THE FIVE SHEATHS. THE OTHER THREE SHEATHS HAVE DIFFERENT OR UNKNOWN LOT NUMBERS AND ARE RECORDED UNDER MEDWATCH REPORT # 1820334-2018-03343 AND 1820334-2018-03390. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING PATIENT DEMOGRAPHICS AND PRE-EXISTING CONDITIONS HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8061200 ↗MalfunctionNov 12, 2018Collapse; Material Frayed; Material Deformation; Collapse; Material Frayed; Material Deformation
IT WAS REPORTED A PEEL-AWAY DENNY SHEATH INTRODUCER SET WAS USED FOR PLACEMENT OF A PERIPHERALLY INSERTED CENTRAL CATHETER IN THE INNER PORTION OF THE UPPER ARM OF THE PATIENT (NO ANOMALIES/PREVIOUS SCARRING). THE PHYSICIAN ACCESSED THE VESSEL WITH ULTRASOUND GUIDANCE AND SUCCESSFULLY ADVANCED THE WIRE. UPON ATTEMPTING TO ADVANCE THE DENNY SHEATH, THE PRODUCT BUCKLED AND THE TIP OF THE SHEATH WAS FOUND TO HAVE FRAYED. THIS HAPPENED A TOTAL OF FIVE TIMES WITH DIFFERENT DENNY SHEATHS EACH TIME. A SIXTH DENNY SHEATH WAS USED SUCCESSFULLY AND ALTHOUGH PROLONGED, THE PROCEDURE WAS COMPLETED. THIS REPORT RECORDS TWO OF THE FIVE SHEATHS. THE OTHER THREE SHEATHS HAVE DIFFERENT OR UNKNOWN LOT NUMBERS AND ARE RECORDED UNDER MEDWATCH REPORT # 1820334-2018-03343 AND 1820334-2018-03344. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING PATIENT DEMOGRAPHICS AND PRE-EXISTING CONDITIONS HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8061199 ↗MalfunctionDec 18, 2017Crack; Crack
THE CUSTOMER REPORTED THAT THE PEEL-AWAY SHEATH INTRODUCER WAS CRACKED AT THE DISTAL END OF THE DEVICE. THIS DEFECT WAS DISCOVERED PRIOR TO USE; ACCORDINGLY, NO PATIENT ADVERSE EVENTS RESULTED FROM THE ISSUE, AND NO CONTACT WITH ANY PATIENT WAS MADE. A NEW PRODUCT WAS OPENED AND THE PROCEDURE CONTINUED, WITH NO FURTHER COMPLICATIONS REPORTED. THE DEVICE HAS BEEN RETURNED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.
Patient problems: No Patient Involvement
MAUDE report 7126864 ↗MalfunctionOct 9, 2017Break; Peeled/Delaminated; Device Dislodged or Dislocated
UPON OPENING THE PACKAGE IN THE BEGINNING OF THE SURGERY, THE NURSE DISCOVERED THE ABNORMAL PEEL OFF BETWEEN THE TOP AND THE TUBE. IT WAS FURTHER NOTED THAT THE SHEATH HAD SEPARATED FROM THE TABS AND THE SHEATH MATERIAL THAT WAS ATTACHED TO THE PULL TABS HAD SIGNS OF THE MATERIAL BEING SLICED. THERE WAS NO HARM TO THE PATIENT AS THE DEVICE DID NOT MAKE PATIENT CONTACT. THE DEVICE WAS IMMEDIATELY SWITCHED WITH ANOTHER BRAND'S INTRODUCER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6930910 ↗MalfunctionOct 9, 2017Device Operates Differently Than Expected
THE .018 WIRES (QUANTITY 2) COULD NOT PASS THRU THE PEEL AWAY SHEATH DURING A PICC LINE INSERTION. IT WAS FURTHER NOTED THAT THE SHAFT OF THE DILATOR WAS ELONGATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME RPN. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6930816 ↗InjuryDec 12, 2014Material Separation
INITIAL INFORMATION PROVIDED STATED THAT THE WIRE GUIDE GOT STUCK IN VESSEL AND COULD NOT BE MOVED. EVENTUALLY THE PHYSICIAN FREED THE WIRE GUIDE, BUT A SMALL PIECE OF PRODUCT REMAINED IN THE PATIENT. ADDITIONAL INFORMATION PROVIDED STATED: "AFTER VEIN PUNCTURE, THEY INSERTED WIRE, BUT THE WIRE WAS NOT IN THE VEIN. THE WIRE GOES PARAVASAL. THEN THEY WANT TO REMOVE THE WIRE, BUT IT WAS NOT POSSIBLE TO REMOVE THE WIRE. THEN THEY REMOVED THE NEEDLE. AFTER THIS THEY REMOVED THE WIRE WITH FULL FORCE. BY THIS THE PLATINUM TIP OF THE WIRE DISBAND, AND BECOME LONGER. THEY REMOVED THE WIRE, ONLY A LITTLE PIECE STUCK IN THE PATIENT'S BODY.
Patient problems: Nonresorbable materials, unretrieved in body
MAUDE report 4346020 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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