ApproachRecalls & reported problems across all models
Cook Incorporated · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one Approach model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls
- 6
We found 11 models of Approach by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Mar 7, 2016 and Oct 16, 2025 — classified as 26 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Material Separation” (35 reports).
6 FDA recall records name at least one of these models by its device identifier, 6 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
Approach 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 5, 2026Open, Classified
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1777-2026 · Root cause: Incorrect or no expiration date · names 2 of these models · Recall details · FDA record ↗
- Mar 5, 2026Open, Classified
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1776-2026 · Root cause: Incorrect or no expiration date · names 2 of these models · Recall details · FDA record ↗
- Mar 5, 2026Open, Classified
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1775-2026 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗
- Oct 14, 2024Open, Classified
Devices from the affected device lots have labels that state the incorrect expiration dates.
Z-0499-2025 · Root cause: Labeling Change Control · Recall details · FDA record ↗
- Oct 8, 2024Open, Classified
Affected device lots have labels that state the incorrect expiration dates.
Z-0347-2025 · Root cause: Labeling Change Control · names 3 of these models · Recall details · FDA record ↗
- Oct 8, 2024Open, Classified
Affected device lots have labels that state the incorrect expiration dates.
Z-0346-2025 · Root cause: Labeling Change Control · names 8 of these models · Recall details · FDA record ↗
Most reported Approach problems
Device problems
- Material Separation35
- Break10
- Unraveled Material9
- Difficult to Remove5
- Peeled/Delaminated5
- Stretched5
- Sticking3
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Consequences Or Impact To Patient18
- No Known Impact Or Consequence To Patient17
- Foreign Body In Patient14
- No Clinical Signs, Symptoms or Conditions12
- No Code Available8
- Device Embedded In Tissue or Plaque5
- No Patient Involvement2
- Loss Of Pulse1
Approach models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Approach G50791Catheter for crossing total occlusions2 recalls15 reports
- Approach G50792Catheter for crossing total occlusions2 recalls7 reports
- Approach G50787Catheter for crossing total occlusions2 recalls2 reports
- Approach G50786Catheter for crossing total occlusions2 recalls1 report
- Approach G50788Catheter for crossing total occlusions2 recalls1 report
- Approach G50789Catheter for crossing total occlusions2 recalls0 reports
- Approach G52939WIRE, GUIDE, CATHETER1 recall24 reports
- Approach G50793Catheter for crossing total occlusions1 recall17 reports
- Approach G50790Catheter for crossing total occlusions1 recall3 reports
- Approach G52938WIRE, GUIDE, CATHETER1 recall1 report
- Approach G52937WIRE, GUIDE, CATHETER1 recall0 reports
Recent Approach adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 16, 2025Break; Break
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
MAUDE report 23312333 ↗InjuryJan 17, 2025Break; Flaked; Break; Flaked
AS REPORTED, DURING A BELOW-THE-KNEE ANGIOPLASTY PROCEDURE INVOLVING THE RIGHT POSTERIOR TIBIAL ARTERY (PTA), THE TIP OF AN APPROACH TO MICROWIRE WIRE GUIDE SEPARATED UPON REMOVAL OF THE DEVICE. ANTEGRADE ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY WITH AN UNKNOWN 4-FRENCH, 11-CENTIMETER SHEATH TO TARGET THE POSTERIOR TIBIAL ARTERY. A DIAGNOSTIC ANGIOGRAM WAS PERFORMED DURING THE PROCEDURE, AS WELL AS ANGIOPLASTY OF THE ANTERIOR TIBIAL ARTERY. THE POSTERIOR TIBIAL ARTERY WAS OCCLUDED AND SEVERELY CALCIFIED, WITHOUT SIGNIFICANT TORTUOSITY. THE WIRE WAS NOT ALTERED PRIOR TO USE. RESISTANCE WAS NOT ENCOUNTERED WHEN THE WIRE WAS INSERTED INTO ANOTHER MANUFACTURER¿S CATHETER; HOWEVER, RESISTANCE WAS REPORTEDLY ENCOUNTERED ¿DURING WIRE DRILLING¿ INTO THE CALCIFIED SEGMENT OF THE VESSEL. THE WIRE BECAME STUCK IN THE CATHETER, WITHIN THE OCCLUDED PTA SEGMENT. THE TIP OF THE WIRE SEPARATED AND UNRAVELED AND REMAINS IN THE OCCLUDED SEGMENT OF THE MID- POSTERIOR TIBIAL ARTERY. THE WIRE WAS NOT PULLED OR MANIPULATED BACKWARDS THROUGH A NEEDLE OR OTHER METAL INSTRUMENT DURING THE PROCEDURE. REPORTEDLY, THE CUSTOMER DOES NOT SUSPECT A MALFUNCTION OF THE WIRE, AS IT BROKE OFF DUE TO A
Patient problems: Foreign Body In Patient
MAUDE report 21183972 ↗InjuryNov 19, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED 14JAN2025. ACCESS WAS OBTAINED IN THE COMMON FEMORAL ARTERY TO TARGET THE PERONEAL ARTERY, WHICH WAS STENOSED AND CALCIFIED. THE WIRE WAS NOT ALTERED PRIOR TO USE, AND "NOT A LOT" OF RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE WIRE. THE WIRE WAS NOT PULLED OR MANIPULATED BACKWARDS THROUGH A NEEDLE OR OTHER METAL INSTRUMENT. THE TIP OF THE WIRE SEPARATED UPON REMOVAL OF THE DEVICE. THE SEPARATED FRAGMENT REMAINS IN THE PERONEAL ARTERY, AS IT COULD NOT BE RETRIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 20727764 ↗MalfunctionJul 15, 2024Break; Break
AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY AND STENT PLACEMENT WITHIN ANOTHER MANUFACTURER'S STENOSED STENT, THE TIP OF AN APPROACH HYDRO ST MICROWIRE WIRE GUIDE SEPARATED IN THE PATIENT AS THE USER ATTEMPTED TO CROSS THE LESION. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY TO TARGET THE LEFT PLANTAR. THE ANATOMY WAS NOT TORTUOUS, SCARRED, OR CALCIFIED. THE WIRE WAS NOT ALTERED PRIOR TO USE. RESISTANCE WAS ENCOUNTERED AS THE DEVICE WAS USED TO CROSS THE LESION AND AGAIN AS THE WIRE WAS REMOVED THROUGH A CXI CATHETER. THE WIRE WAS NOT MANIPULATED BACKWARDS OR PULLED THROUGH THE NEEDLE. THE SEPARATED WIRE FRAGMENT WAS REMOVED WITH A MICRO SNARE AND THE CATHETER AND WIRE WERE REMOVED. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. 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 19742432 ↗InjuryMay 6, 2024Break; Unraveled Material; Break; Unraveled Material
ADDITIONAL INFORMATION WAS RECEIVED 02MAY2024. THE WIRE WAS NOT ALTERED PRIOR TO USE. ACCESS WAS OBTAINED IN THE PEDAL AND FEMORAL ARTERIES FOR THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED AS THE WIRE WAS ADVANCED THROUGH THE PEDAL ACCESS SITE. THE ANATOMY WAS CALCIFIED AND HIGHLY STENOSED, WITH SINGLE VESSEL RUNOFF AND CHRONIC TOTAL OCCLUSION IN THE POPLITEAL ARTERY. THE TIP OF THE WIRE SHEARED OFF WHEN IT BECAME CAUGHT BETWEEN THE TIP OF A CXI CATHETER AND PROTRUDING CALCIUM IN THE ANTERIOR TIBIAL ARTERY. RESISTANCE WAS ¿POTENTIALLY¿ ENCOUNTERED UPON REMOVAL OF THE WIRE THROUGH THE CATHETER. THE WIRE WAS NOT REMOVED OR MANIPULATED THROUGH A NEEDLE OR METAL INSTRUMENT DURING THE PROCEDURE. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 19254326 ↗MalfunctionNov 1, 2023Break; Unraveled Material; Break; 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
MAUDE report 18049861 ↗InjuryOct 23, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED 27OCT2023. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. THE ANATOMY WAS HEAVILY CALCIFIED AND THE DORSALIS PEDIS ARTERY WAS 80% OCCLUDED. THE WIRE WAS NOT ALTERED PRIOR TO USE. RESISTANCE WAS NOT FELT UPON INSERTION OF THE WIRE AND THE WIRE WAS NOT MANIPULATED/PULLED BACKWARD THROUGH THE NEEDLE OR ANY OTHER METAL INSTRUMENT.
Patient problems: Foreign Body In Patient
MAUDE report 17986636 ↗MalfunctionOct 17, 2023Unraveled Material; Unraveled Material
AS REPORTED, DURING A PROCEDURE INVOLVING INTERVENTION OF THE SUPERFICIAL FEMORAL ARTERY, THE TIP OF AN APPROACH CTO MICROWIRE WIRE GUIDE UNRAVELED. ACCESS WAS OBTAINED THROUGH THE POSTERIOR TIBIAL ARTERY TO TREAT THE CHRONIC TOTALLY OCCLUDED (CTO) SUPERFICIAL FEMORAL ARTERY. THE PATIENT'S ANATOMY WAS CALCIFIED. THE WIRE WAS FULLY ADVANCED THROUGH A COOK CXI CATHETER AND UPON MOVING THE WIRE "IN AND OUT OF THE CATHETER" THE TIP SEPARATED BUT DID NOT DETACH. THE WIRE WAS REMOVED AND REPLACED WITH ANOTHER WIRE GUIDE. PER THE REPORTER, RESISTANCE WAS NOT FELT UPON INSERTION OF THE WIRE; HOWEVER, RESISTANCE WAS FELT WHILE ADVANCING THROUGH THE CTO. 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 OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17950938 ↗MalfunctionOct 3, 2023Material Separation; Difficult to Advance; Scratched Material; Material Separation; Difficult to Advance; Scratched Material
AS ORIGINALLY REPORTED, DURING AN INTERVENTIONAL PROCEDURE OF THE SUPERFICIAL FEMORAL AND POSTERIOR TIBIAL ARTERIES, THE TIP OF AN APPROACH CTO MICROWIRE WIRE GUIDE 'SEPARATED' WITHIN A CHRONIC, TOTALLY OCCLUDED LESION (100% OCCLUDED) IN THE POSTERIOR TIBIAL ARTERY. THE WIRE WAS NOT ALTERED PRIOR TO USE. THE PATIENT'S ANATOMY WAS CALCIFIED, AND RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE WIRE INTO THE LESION. ALTHOUGH THE WIRE TIP 'SEPARATED', THE TIP REPORTEDLY DID NOT BREAK OFF. A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE. DURING THE SAME PROCEDURE, A MICRO BALLOON WAS UNABLE TO CROSS A LESION AND ANOTHER BALLOON RUPTURED IN THE SUPERFICIAL FEMORAL ARTERY AFTER AN ATHERECTOMY WAS PERFORMED. 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. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE TIP OF THE WIRE WAS DAMAGED, WITH PARTIAL SEPARATION OF THE GREEN COATING ON THE DISTAL TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17862824 ↗MalfunctionAug 8, 2023Material 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 Clinical Signs, Symptoms or Conditions
MAUDE report 17482339 ↗InjurySep 16, 2022Break; Break
AS REPORTED, AN APPROACH HYDRO ST WIRE SEPARATED DURING AN UNSPECIFIED PROCEDURE. THE DEVICE WAS ADVANCED THROUGH HEAVILY CALCIFIED VESSELS IN AN ATTEMPT TO GO THROUGH AN OCCLUSION. WHEN THE DEVICE WAS WITHDRAWN, THE TIP OF THE DEVICE WAS FOUND TO BE SEPARATED AND STUCK WITHIN THE CALCIFICATION. THE DEVICE TIP WAS UNABLE TO BE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS ABANDONED DUE TO THE INABILITY TO CANNULATE THE VESSEL. THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT. ADDITIONAL EVENT DETAILS HAVE BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 15439679 ↗MalfunctionAug 24, 2022Break; Stretched; Unraveled Material; Break; Stretched; Unraveled Material
AS REPORTED, DURING AN UNSPECIFIED "PEDAL CASE" INVOLVING TIBIAL LESIONS, AN APPROACH HYDRO ST MICROWIRE WIRE GUIDE SEPARATED AND FRAYED. PEDAL ACCESS WAS REPORTEDLY DIFFICULT, REQUIRING MULTIPLE ACCESS KITS. THE VESSELS WERE EXTREMELY CALCIFIED, AND RESISTANCE WAS ENCOUNTERED WITH MULTIPLE PRODUCTS DURING THE CASE, INCLUDING THE COMPLAINT DEVICE. THE WIRE GUIDE, WHICH WAS NOT ALTERED PRIOR TO USE, WAS ADVANCED TOWARDS THE TIBIAL PERONEAL TRUNK, AND A COOK PTA BALLOON WAS ADVANCED OVER THE WIRE. AFTER INFLATING THE BALLOON, THE PHYSICIAN ATTEMPTED TO ADVANCE THE WIRE WHILE THE BALLOON WAS STILL INFLATED. THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE AFTER DEFLATING THE BALLOON; HOWEVER, THE WIRE BECAME STUCK IN THE BALLOON CATHETER AND SUBSEQUENTLY FRAYED AND SEPARATED. THE PHYSICIAN WAS ABLE TO REMOVE THE WIRE, BUT A PIECE OF THE WIRE REMAINED INSIDE THE BALLOON CATHETER. THE PHYSICIAN CUT THE BALLOON CATHETER AND WAS ABLE TO REMOVE THE CATHETER AND WIRE. 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 DU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15287147 ↗MalfunctionJun 27, 2022Peeled/Delaminated; Peeled/Delaminated
AS REPORTED, DURING AN ANGIOGRAM, AN APPROACH HYDRO ST MICROWIRE WIRE GUIDE'S HYDROPHILIC COATING DETACHED AND APPEARED TO BE "FRAYED". ACCESS WAS OBTAINED IN THE GROIN TO TARGET THE SUPERFICIAL FEMORAL ARTERY. THE ANATOMY WAS NOT TORTUOUS OR CALCIFIED. THE WIRE, WHICH WAS NOT ALTERED PRIOR TO USE, WAS FLUSHED WITH HEPARINIZED SALINE TO ACTIVATE THE COATING. THE WIRE WAS USED ONE TIME ONLY. THE COATING DID NOT FLAKE. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 14827867 ↗InjuryDec 28, 2021Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent
AS REPORTED VIA A MEDWATCH REPORT, DURING AN UNSPECIFIED PROCEDURE, AN APPROACH CTO MICROWIRE WIRE GUIDE KINKED AND BECAME STUCK IN THE VESSEL. AN UNKNOWN ANGIOPLASTY BALLOON AND SHEATH WERE USED WITH THE WIRE. "PART WAY" THROUGH THE PROCEDURE, THE WIRE BENT AND WAS UNABLE TO BE WITHDRAWN FROM THE PATIENT. AN UNKNOWN 6 FRENCH CATHETER WAS ADVANCED IN AN ATTEMPT TO STRAIGHTEN THE KINK IN THE WIRE; HOWEVER, THIS WAS UNSUCCESSFUL. THE SURGEON THEN DECIDED TO PERFORM A CUT-DOWN OF THE LEFT GROIN TO AVOID DAMAGING THE VESSELS OR EQUIPMENT, AND THE WIRE WAS REMOVED UNDER DIRECT VISUALIZATION. THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13094625 ↗MalfunctionSep 14, 2021Unraveled Material; Unraveled Material
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469400 ↗
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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