Rosen G01264Recalls & reported problems
Cook Incorporated · Rosen Curved Wire Guide · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002012646), received between Jun 25, 2018 and May 10, 2019 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Aug 16, 2022Open, Classified
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Z-1842-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component2
- Break1
- Stretched1
Patient problems
- No Known Impact Or Consequence To Patient2
- Sepsis2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Sepsis
MAUDE report 8598099 ↗MalfunctionSep 21, 2018Stretched; Detachment of Device or Device Component
THE COMPLAINANT REPORTED THAT THE DISTAL PART OF THE SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE WAS STRETCHED, BUT STILL INTACT. IT WAS FURTHER NOTED THAT THE DISTAL WELD CONNECTION SEPARATED FROM THE COIL AND SAFETY WIRE WHICH RESULTED IN COIL ELONGATION. THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7898731 ↗MalfunctionSep 21, 2018Break; Detachment of Device or Device Component
THE COMPLAINANT REPORTED THAT THE INNER COIL SEPARATED DURING SHAPING OF THE SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE. IT WAS FURTHER NOTED THAT THE TIP WELD WAS BROKEN. THE WIRE WAS NOT USED IN THE PATIENT, AND THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7897826 ↗InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, A FEMALE PATIENT IN HER "EARLY 60'S" WITH A NON-HEALING, LEFT FOOT, VASCULAR ULCER, UNDERWENT A STENT PLACEMENT (SITE NOT SPECIFIED) ON (B)(6) 2018 IN AN OUTPATIENT FACILITY. MULTIPLE COOK PRODUCTS WERE USED. ON (B)(6) 2018, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A FEVER (TEMPERATURE UNKNOWN TO COMPLAINANT) AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS DIAGNOSED WITH SEPSIS WHICH WAS TREATED WITH "FLUIDS AND IV ANTIBIOTICS" AND IS "DOING FINE". REPORTEDLY, LAB RESULTS INDICATE A STRAIN OF STREP WAS IDENTIFIED, HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. PER THE COMPLAINANT: "SEVERAL COOK PRODUCTS WERE INVOLVED WITH ORIGINAL PROCEDURE, UNKNOWN AND NOT ALLEGED AT THIS TIME IF ANY OF THEM MAY HAVE CONTRIBUTED TO THIS." ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND RELEVANT MEDICAL HISTORY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. PLEASE REFERENCE ADDITIONAL MEDWATCH NUMBERS REGARDING ALL COOK PRODUCTS IN USE DURING THE PROCEDURE: CID-20-30-NG (1820334-2018-01470) KCFW-5.0-38-RB (1820334-2018-01613), KCFW-6.0-18/38-45-RB-ANL0-HC (1820334-2018-01614), MPIS-402-NT-U-SST (1820334-2018-01615), PTA5-35-135-6-6.0 (18203
Patient problems: Sepsis
MAUDE report 7634294 ↗
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- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.