RosenRecalls & reported problems across all models
Cook Incorporated · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Rosen model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 1
We found 5 models of Rosen by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2017 and Apr 2, 2025 — classified as 6 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (6 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
Reports received per month, all models
Rosen 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.
- 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 · names 4 of these models · Recall details · FDA record ↗
Most reported Rosen problems
Device problems
- Unraveled Material6
- Adverse Event Without Identified Device or Use Problem5
- Break4
- Material Protrusion/Extrusion3
- Detachment of Device or Device Component2
- Material Frayed2
- Material Separation2
- Stretched2
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Known Impact Or Consequence To Patient6
- No Consequences Or Impact To Patient4
- Insufficient Information3
- No Patient Involvement3
- Vascular Dissection3
- Sepsis2
- Hemorrhage/Blood Loss/Bleeding1
Rosen models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Rosen G01264WIRE, GUIDE, CATHETER1 recall4 reports
- Rosen G01261WIRE, GUIDE, CATHETER1 recall1 report
- Rosen G01774WIRE, GUIDE, CATHETER1 recall1 report
- Rosen G01623WIRE, GUIDE, CATHETER1 recall0 reports
- Rosen G01253WIRE, GUIDE, CATHETER21 reports
Recent Rosen adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, DURING A PROCEDURE INVOLVING ANEURYSM REPAIR AND STENT GRAFT PLACEMENT, DURING WHICH A SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE (REPORTED UNDER PATIENT IDENTIFIER (B)(6) AND A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE (REPORTED UNDER PATIENT IDENTIFIER (B)(6) WERE USED, THE PATIENT EXPERIENCED A DISSECTION OF THE LEFT SUBCLAVIAN ARTERY. GENERAL ANESTHESIA WAS ADMINISTERED FOR THE PROCEDURE, AND PERCUTANEOUS ACCESS WAS OBTAINED IN THE LEFT AND RIGHT FEMORAL ARTERIES. CUT-DOWN ACCESS WAS OBTAINED IN THE RIGHT AXILLARY ARTERY. A 9X57 PERIPHERAL STENT WAS SUCCESSFULLY PLACED IN THE LEFT SUBCLAVIAN ARTERY, WHICH WAS RE-VASCULARIZED WITH A FENESTRATED BRANCHED DEVICE. STENT PATENCY WAS MAINTAINED, WITH NORMAL END ARTERY PERFUSION. THE WIRES USED DURING THE PROCEDURE SUCCESSFULLY ACCESSED THE TARGET VASCULATURE AND PERFORMED AS INTENDED, WITHOUT ANY NOTED DEVICE DEFICIENCIES. A LEFT SUBCLAVIAN ARTERY INJURY (DISSECTION) WAS REPORTED DURING THE PROCEDURE; HOWEVER, THE INJURY DID NOT REQUIRE TREATMENT. PER THE REPORTER, THE INJURY WAS CAUSALLY RELATED TO A STENT, AS THE DISSECTION OCCURRED AFTER PLACEMENT OF THE BRIDGING STENT, WHILE POSITIONING THE DEVICE. PER THE REP
Patient problems: Vascular Dissection
MAUDE report 21753761 ↗InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, SIX DAYS AFTER AN UNSPECIFIED PROCEDURE, DURING WHICH FOUR SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDES WERE USED, A DISSECTION OF THE RIGHT RENAL ARTERY WAS NOTED, WHICH WAS TREATED CONSERVATIVELY. PER THE REPORTER, THE DISSECTION OCCURRED AFTER PLACEMENT OF BRIDGING STENTS AND WAS CONSIDERED POSSIBLY RELATED TO A COOK WIRE GUIDE, AS THE EVENT ¿COULD HAVE OCCURRED¿ DURING CANNULATION OF THE VESSEL. THE EVENT WAS CONSIDERED CAUSALLY RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE TREATED DISEASE AND ¿PATHOLOGICAL VESSEL WALLS¿. PER THE USER/REPORTER, THE EVENT DID NOT OCCUR DUE TO A DEVICE DEFICIENCY. THE USER COULD NOT SPECIFY WHAT DEVICE WAS INVOLVED EXACTLY. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: Renal Impairment; Vascular Dissection
MAUDE report 21738026 ↗InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, A SIXTY-NINE-YEAR-OLD MALE WITH A TYPE IV THORACOABDOMINAL ANEURYSM UNDERWENT A PROCEDURE INVOLVING FENESTRATED ENDOVASCULAR AORTIC ANEURYSM REPAIR WITH STENT PLACEMENT WITHIN THE CELIAC ARTERY (CA), SUPERIOR MESENTERIC ARTERY (SMA), RIGHT RENAL ARTERY (RRA), AND LEFT RENAL ARTERY (LRA), ANGIOPLASTY OF THE LEFT EXTERNAL ILIAC ARTERY (EIA), AND INTRAVENOUS ULTRASOUND. THE RENAL ARTERIES WERE ¿RELATIVELY SMALL¿ IN DIAMETER. THE LENGTH FROM THE OSTIUM OF THE LEFT RENAL ARTERY TO THE FIRST MAJOR BIFURCATION WAS 41.2-MILLIMETERS, AND THE DIAMETER OF THE LRA AT THE LOCATION OF INTENDED DISTAL LANDING ZONE WAS 4.0-MILLIMETERS. THE LRA WAS LESS THAN 50% STENOSED, AND THERE WAS A POTENTIAL EXCESSIVE GAP AT THE LEVEL OF THE LRA. THE RIGHT AND LEFT COMMON AND EXTERNAL ILIAC ARTERIES WERE MODERATELY CALCIFIED, WITH MULTIPLE AREAS OF FOCAL STENOSIS. THE FEMORAL ARTERIES WERE MILDLY CALCIFIED. THE ILIAC ARTERIES WERE NOT TORTUOUS. THE ANGLE OF THE LEFT RENAL ARTERY WITH RESPECT TO THE AORTA WAS SIXTY-DEGREES. GENERAL ANESTHESIA WAS ADMINISTERED, AND ENDOTRACHEAL INTUBATION WAS PERFORMED. ANTIBIOTICS WERE ADMINISTERED. OVERLAY FLUOROSCOPY WAS OBTAINED TO PROVIDE ON-SCREEN MARKINGS DU
Patient problems: Thrombosis/Thrombus; Vascular Dissection
MAUDE report 20696544 ↗MalfunctionAug 19, 2024Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20000401 ↗MalfunctionFeb 20, 2023Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. UPON RETURN AND EVALUATION OF THE COMPLAINT DEVICE, THE WIRE WAS NOT UNRAVELED AS INITIALLY REPORTED. THE WIRE WAS BENT IN A CORKSCREW SHAPE, BUT NO OTHER DAMAGE WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16405656 ↗MalfunctionOct 7, 2022Break; Break
AS REPORTED, THE TIP OF A SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE WAS "BROKEN". ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15564186 ↗MalfunctionSep 9, 2022Break; Unraveled Material; Break; Unraveled Material
AS REPORTED, DURING A THROMBECTOMY PROCEDURE FOR TREATMENT OF A DEEP VEIN THROMBOSIS, A SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE UNRAVELED. ACCESS WAS OBTAINED IN THE RIGHT INTERNAL JUGULAR VEIN AND THE WIRE WAS ADVANCED TO THE DISTAL VENA CAVA. THE PATIENT WAS FLIPPED FOR ACCESS INTO THE POPLITEAL VEIN, AS THE USER INTENDED TO ADVANCE THE WIRE THROUGH ANOTHER 16 FRENCH SHEATH. THE WIRE WAS SNARED AND EVERYTHING APPEARED "FINE"; HOWEVER, THE WIRE UNRAVELED IN THE MIDDLE OF THE FEMORAL VEIN BEFORE REACHING THE SHEATH. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THAT THE WIRE UNRAVELED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15390607 ↗MalfunctionAug 17, 2022Break; Unraveled Material; Break; Unraveled Material
AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE TIP OF A SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE "FELL APART" AND SEPARATED FROM THE INNER WIRE WHILE THE USER ATTEMPTED TO STRAIGHTEN THE TIP. PER THE CUSTOMER, THIS OCCURRED ON THE BACK TABLE AFTER THE DEVICE WAS REMOVED FROM THE PATIENT. THE WIRE WAS NOT ALTERED PRIOR TO USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15239576 ↗MalfunctionApr 27, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
AS REPORTED, FOLLOWING AN UNSPECIFIED PROCEDURE, A SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE FRAYED. THE INNER MANDRIL PROTRUDED APPROXIMATELY 3-4CM FROM THE TIP OF THE DEVICE AND CUT THE FINGER OF THE PHYSICIAN HANDLING THE DEVICE. THE PHYSICIAN'S FINGER WAS REPORTED TO BE "FINE". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. UPON RETURN EVALUATION OF THE DEVICE, THE WELD WAS BROKEN FREE OF THE SAFETY WIRE BUT WAS STILL ATTACHED TO THE COIL.
Patient problems: Laceration(s)
MAUDE report 14220466 ↗MalfunctionJul 1, 2021Flaked; Flaked
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12103580 ↗InjuryMay 18, 2021Material Separation; Material Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 11841736 ↗MalfunctionMar 25, 2021Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11569250 ↗MalfunctionJan 20, 2021Unraveled 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11201017 ↗MalfunctionJan 7, 2021Material Frayed; Stretched; Material Frayed; Stretched
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11133910 ↗MalfunctionOct 26, 2020Material Separation; Material Separation
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 10733034 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page