Advance MicroRecalls & reported problems across all models
Cook Incorporated · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 25 models of Advance Micro by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Jul 17, 2017 and Dec 9, 2024 — classified as 2 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (12 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. 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
Most reported Advance Micro problems
Device problems
- Material Rupture12
- Material Separation11
- Break10
- Difficult to Remove4
- Fluid/Blood Leak2
- Leak/Splash2
- Sticking2
- Stretched2
Patient problems
- No Known Impact Or Consequence To Patient15
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient8
- Foreign Body In Patient1
- No Code Available1
Advance Micro models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Advance Micro G26641Catheter, angioplasty, peripheral, transluminal5 reports
- Advance Micro G26407Catheter, angioplasty, peripheral, transluminal4 reports
- Advance Micro G26724Catheter, angioplasty, peripheral, transluminal3 reports
- Advance Micro G26119Catheter, angioplasty, peripheral, transluminal2 reports
- Advance Micro G26614Catheter, angioplasty, peripheral, transluminal2 reports
- Advance Micro G26626Catheter, angioplasty, peripheral, transluminal2 reports
- Advance Micro G26679Catheter, angioplasty, peripheral, transluminal2 reports
- Advance Micro G26719Catheter, angioplasty, peripheral, transluminal2 reports
- Advance Micro G26095Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26098Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26117Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26195Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26401Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26405Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26601Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26605Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26610Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26611Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26622Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26625Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26636Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26653Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26677Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26678Catheter, angioplasty, peripheral, transluminal1 report
- Advance Micro G26710Catheter, angioplasty, peripheral, transluminal1 report
Recent Advance Micro adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2024Fluid/Blood Leak; 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 20884561 ↗MalfunctionSep 30, 2024Break; Break
AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY OF THE ANTERIOR TIBIAL ARTERY, AN ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER SEPARATED. ACCESS WAS OBTAINED IN THE PEDAL ARTERY, USING A COOK PEDAL ACCESS SET. SINGLE FEMORAL ACCESS WAS ALSO OBTAINED. THE BALLOON CATHETER TRACKED NORMALLY THROUGH THE LESION, AND THE BALLOON WAS INFLATED AND DEFLATED, COMPLETING THE PROCEDURE. WHEN THE USER REPORTEDLY ¿PINCHED¿ THE SHAFT OF THE DEVICE BETWEEN HIS FINGERS TO REMOVE IT, THE SHAFT BROKE WHERE IT WAS ¿PINCHED¿. THE USER PULLED SOME OF THE SHAFT OUT AND READJUSTED HIS FINGERS; HOWEVER, THE SHAFT BROKE AGAIN. REPORTEDLY, THIS HAPPENED SEVERAL TIMES BEFORE THE TIP SEPARATED IN THE PATIENT. PER THE REPORTER, RESISTANCE WAS NOT ENCOUNTERED UPON REMOVAL OF THE CATHETER UNTIL THE SHAFT SEPARATED AND CONTINUED TO BREAK. THE SEPARATED PORTION OF THE CATHETER REMAINED ON THE WIRE GUIDE; THEREFORE, THE USER EXTERNALIZED THE WIRE GUIDE FROM A FEMORAL APPROACH, AND A COOK CXI CATHETER WAS ADVANCED FROM THE FEMORAL SITE AND USED TO PUSH THE TIP OF THE DEVICE INTO THE PEDAL ACCESS SHEATH. THE SEPARATED PORTION OF THE COMPLAINT DEVICE WAS SUCCESSFULLY REMOVED. THE HOSPITAL LENGTH OF STA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340436 ↗MalfunctionJul 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
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 19645629 ↗MalfunctionMay 1, 2024Difficult to Remove; Material Separation; Material Deformation; Difficult to Remove; Material Separation; Material Deformation
ADDITIONAL INFORMATION WAS RECEIVED 16MAY2024. IT IS UNKNOWN WHAT WIRE WAS USED. THE BALLOON CATHETER'S WIRE LUMEN WAS FLUSHED WITH HEPARINIZED SALINE. THE USER DID NOT ATTEMPT TO INFLATE THE BALLOON PRIOR TO ADVANCEMENT OVER THE WIRE. THE BALLOON CATHETER DID NOT ENTER THE SHEATH AND IT WAS NOT INSERTED INTO THE PATIENT. IT IS UNKNOWN FOR CERTAIN IF THE BALLOON CATHETER WAS ADVANCED USING A COUNTERCLOCKWISE ROTATION. THE USER WAS UNABLE TO REMOVE THE BALLOON CATHETER FROM THE WIRE AFTER THE WIRE WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19220935 ↗InjuryApr 30, 2024Break; Material Rupture; Break; Material Rupture
ADDITIONAL INFORMATION WAS RECEIVED 23APR2024. UNSPECIFIED 6-MILLIMETER BY 4-CENTIMETER, 2-MILLIMETER BY 100-MILLIMETER, AND 5-MILLIMETER BY 4-CENTIMETER BALLOONS WERE ALSO USED DURING THE PROCEDURE, AS WELL AS A 6-MILLIMETER BY 80-MILLIMETER ZILVER FLEX STENT.
Patient problems: Foreign Body In Patient
MAUDE report 19214756 ↗MalfunctionMar 27, 2024Material Rupture; Material Rupture
AS REPORTED, DURING A BELOW-THE-KNEE ANGIOPLASTY VIA ANTEGRADE ACCESS, AN ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER RUPTURED. ANOTHER MANUFACTURER'S 6-FRENCH SHEATH WAS USED DURING THE PROCEDURE. THE COMPLAINT DEVICE WAS REPORTEDLY DIFFICULT TO TRACK TO THE LESION DUE TO CALCIFICATION, WHICH WAS NOTED DURING WIRE ADVANCEMENT AND IMAGING. THE BALLOON CATHETER COULD NOT TRACK MORE THAN SEVEN CENTIMETERS FROM THE START OF THE PROXIMAL SEGMENT OF THE VESSEL. THE BALLOON WAS INFLATED ONE TIME WITHIN A STENOSED LESION IN THE PROXIMAL SECTION OF A CRURAL VESSEL, USING ANOTHER MANUFACTURER'S INFLATION DEVICE, TO APPROXIMATELY SIX-TO-EIGHT ATMOSPHERES; HOWEVER, THE BALLOON RUPTURED LONGITUDINALLY. THE ENTIRE LENGTH OF THE VESSEL WAS SIGNIFICANTLY CALCIFIED AND HAD POOR RUN OFF, WITH "THREADY" AND "PATCHY" FLOW ALONG THE LENGTH OF THE VESSEL. BLOOD WAS NOT NOTED IN THE INFLATION DEVICE, AND THE BALLOON WAS NOT INFLATED WITHIN A STENT. THE DEVICE WAS RETRIEVED THROUGH THE SHEATH, USING AN UNSPECIFIED SNARE. TREATMENT OF OTHER VESSELS WAS COMPLETED WITH ANOTHER BALLOON; HOWEVER, THE VESSEL BEING TREATED AT THE TIME OF THIS EVENT WAS LEFT UNTREATED, DUE TO CALCIFICATION AND OTHER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18988249 ↗MalfunctionDec 18, 2023Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance
ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2024. THE DEVICE SEPARATED AS IT WAS PULLED BACK OUT OF THE CATHETER. THE BALLOON WAS NOT INFLATED, AS THE CATHETER WOULD NOT ADVANCE ACROSS THE LESION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18347152 ↗MalfunctionSep 5, 2023Break; Difficult to Remove; Break; Difficult to Remove
ADDITIONAL INFORMATION WAS RECEIVED 24OCT2023. DIRECT ACCESS WAS OBTAINED IN THE FEMORAL ARTERY, AND A CONTRALATERAL APPROACH WAS USED TO TARGET THE POSTERIOR TIBIAL ARTERY. THE BIFURCATION WAS NOT STEEP OR CALCIFIED; HOWEVER, THE ANATOMY WAS STENOSED, WITH CALCIFIED PLAQUES ALONG THE "PATH". A COOK SHEATH WAS USED DURING THE PROCEDURE. THE BALLOON DID NOT RUPTURE, AND BLOOD WAS NOT NOTED IN THE INFLATION DEVICE. THE BALLOON WAS RETURNED TO AMBIENT PRESSURE ONCE DEFLATED, AND NEGATIVE PRESSURE WAS MAINTAINED UPON REMOVAL. A COUNTERCLOCKWISE ROTATION OF THE DEVICE WAS NOT CONDUCTED UPON WITHDRAWAL. THE CATHETER FRAGMENTS WERE STUCK TO THE WIRE GUIDE; THEREFORE, THE USER REMOVED THE WIRE GUIDE AND CATHETER PIECES TOGETHER, BY PULLING ON THE WIRE GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17681992 ↗MalfunctionMar 27, 2023Material Rupture; Material Rupture
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 16620610 ↗MalfunctionMar 23, 2023Fluid/Blood Leak; 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 16599949 ↗MalfunctionMay 9, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, PRIOR TO USE DURING AN ANGIOPLASTY PROCEDURE INVOLVING THE RIGHT PELVIC LIMB, AN UNKNOWN METAL FILAMENT WAS FOUND INSIDE OF AN ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER. THE PACKAGE WAS OPENED AND THE PLASTIC COVER WAS REMOVED FROM THE DISTAL CATHETER. THE USER THEN ATTEMPTED TO FLUSH THE DEVICE; HOWEVER, THE CATHETER WOULD NOT FLUSH, AS A LONG METAL FILAMENT WAS NOTED INSIDE THE CATHETER LUMEN. THE FILAMENT WAS REPORTEDLY VERY DIFFICULT TO REMOVE AND APPEARED TO BE STUCK TO THE "PLASTIC MEMBRANE" OF THE CATHETER. THE USER WAS ABLE TO FLUSH THE CATHETER ONCE THE FILAMENT WAS SEPARATED FROM THE DEVICE. THE USER THEN ATTEMPTED TO INFLATE THE BALLOON OUTSIDE OF THE PATIENT; HOWEVER THE BALLOON INFLATED IRREGULARLY, WITH SOME LIQUID REMAINING IN PARTS OF THE BALLOON AFTER DEFLATION. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 14338346 ↗MalfunctionApr 18, 2022Break; Break
AS REPORTED, DURING A LOWER LIMB ANGIOPLASTY, AN ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER SEPARATED. "BARE BACK" RETROGRADE ANTERIOR TIBIAL ACCESS WAS OBTAINED. REPORTEDLY, TWO BALLOON CATHETERS WERE DIFFICULT TO ADVANCE OVER A 0.014-INCH WIRE. THE COMPLAINT DEVICE WAS ALSO DIFFICULT TO RETRACT AND SUBSEQUENTLY SEPARATED DURING REMOVAL. 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 14136789 ↗MalfunctionFeb 2, 2022Break; Crack; Break; Crack
AS REPORTED, DURING AN ANGIOGRAM OF THE POPLITEAL ARTERY THE HUB OF A ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER BROKE. THE BALLOON WAS ADVANCED THROUGH ANOTHER MANUFACTURER'S 6FR SHEATH TO THE TARGET LOCATION. IT WAS INFLATED USING AN ADVANTAGE KIT WITH A 50/50 SOLUTION OF SALINE AND CONTRAST. THE HUB OF THE DEVICE THEN BROKE WHILE "TWISTING". THE BALLOON WAS THEN REMOVED AS A UNIT AND THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. IT WAS NOTED THAT THE ANATOMY WAS NOT TORTUOUS, BUT WAS MODERATELY TO SEVERELY CALCIFIED. 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. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13422741 ↗MalfunctionNov 22, 2021Material Rupture; Material Rupture
ASA REPORTED, DURING A PERIPHERAL ARTERY DISEASE PROCEDURE AN ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER WAS BEING USED, AND THE BALLOON RUPTURED. THE BALLOON WAS INFLATED ONCE AND UPON THE SECOND INFLATION THE BALLOON RUPTURE OCCURRED. THE DEVICE WAS USED WITH A VIPER 014 WIRE, AND A 6FR 12CM ACCESS SHEATH WAS UTILIZED. A COOK INFLATION DEVICE WAS ALSO USED. THE BALLOON WAS INFLATED TO 8ATM. JUST THE BALLOON WAS REMOVED FOLLOWING THE MALFUNCTION. THE PATIENT DID HAVE CALCIFIED ANATOMY. THE LESION WAS LOCATED JUST BELOW THE TIBIAL TRUNK OF THE PERONEAL ARTERY, AND THE VESSEL WAS OCCLUDED LESS THAN 10 PERCENT. THE BALLOON WAS NO INFLATED INSIDE OF A STENT PRIOR TO RUPTURE. A SAME TYPE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12856134 ↗MalfunctionJun 1, 2021Material Rupture; Material Separation; Material Rupture; Material Separation
UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE, THE BALLOON CATHETER WAS NOTED TO BE SEPARATED INTO TWO SECTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11914081 ↗
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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