AdvanceRecalls & reported problems across all models
Cook Incorporated · 206 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 816
- Deaths reported
- 2
- Injuries reported
- 148
- Recalls
- 0
We found 206 models of Advance by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 816 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2014 and Sep 19, 2025 — classified as 2 deaths, 148 injuries, 666 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (536 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 problems
Device problems
- Material Rupture536
- Material Separation111
- Fluid/Blood Leak56
- Material Puncture/Hole52
- Break32
- Leak/Splash31
- Hole In Material24
- Inflation Problem24
Patient problems
- No Known Impact Or Consequence To Patient301
- No Consequences Or Impact To Patient200
- No Clinical Signs, Symptoms or Conditions167
- No Code Available82
- Foreign Body In Patient46
- Device Embedded In Tissue or Plaque21
- Insufficient Information18
- No Patient Involvement18
Advance models
206 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Advance G52359CATHETER, PERCUTANEOUS1 death31 reports
- Advance G30958Catheter, angioplasty, peripheral, transluminal22 reports
- Advance G35532Catheter, angioplasty, peripheral, transluminal22 reports
- Advance G50326Catheter, angioplasty, peripheral, transluminal22 reports
- Advance G52352CATHETER, PERCUTANEOUS22 reports
- Advance G50338Catheter, angioplasty, peripheral, transluminal19 reports
- Advance G52332CATHETER, PERCUTANEOUS17 reports
- Advance G52338CATHETER, PERCUTANEOUS17 reports
- Advance G50333Catheter, angioplasty, peripheral, transluminal16 reports
- Advance G50317Catheter, angioplasty, peripheral, transluminal14 reports
- Advance G50335Catheter, angioplasty, peripheral, transluminal14 reports
- Advance G30964Catheter, angioplasty, peripheral, transluminal13 reports
- Advance G52345CATHETER, PERCUTANEOUS13 reports
- Advance G52361CATHETER, PERCUTANEOUS13 reports
- Advance G50319Catheter, angioplasty, peripheral, transluminal12 reports
- Advance G50328Catheter, angioplasty, peripheral, transluminal12 reports
- Advance G30946Catheter, angioplasty, peripheral, transluminal11 reports
- Advance G50314Catheter, angioplasty, peripheral, transluminal11 reports
- Advance G50340Catheter, angioplasty, peripheral, transluminal11 reports
- Advance G52260CATHETER, PERCUTANEOUS11 reports
- Advance G52360CATHETER, PERCUTANEOUS11 reports
- Advance G50313Catheter, angioplasty, peripheral, transluminal10 reports
- Advance G50324Catheter, angioplasty, peripheral, transluminal10 reports
- Advance G35536Catheter, angioplasty, peripheral, transluminal9 reports
- Advance G52270CATHETER, PERCUTANEOUS9 reports
- Advance G52272CATHETER, PERCUTANEOUS9 reports
- Advance G52279CATHETER, PERCUTANEOUS9 reports
- Advance G50321Catheter, angioplasty, peripheral, transluminal8 reports
- Advance G52358CATHETER, PERCUTANEOUS8 reports
- Advance G35527Catheter, angioplasty, peripheral, transluminal7 reports
- Advance G52251CATHETER, PERCUTANEOUS7 reports
- Advance G52252CATHETER, PERCUTANEOUS7 reports
- Advance G52293CATHETER, PERCUTANEOUS7 reports
- Advance G52353CATHETER, PERCUTANEOUS7 reports
- Advance G52373CATHETER, PERCUTANEOUS7 reports
- Advance G52265CATHETER, PERCUTANEOUS6 reports
- Advance G52333CATHETER, PERCUTANEOUS6 reports
- Advance G52354CATHETER, PERCUTANEOUS6 reports
- Advance G50331Catheter, angioplasty, peripheral, transluminal5 reports
- Advance G52258CATHETER, PERCUTANEOUS5 reports
- Advance G52340CATHETER, PERCUTANEOUS5 reports
- Advance G52347CATHETER, PERCUTANEOUS5 reports
- Advance G52351CATHETER, PERCUTANEOUS5 reports
- Advance G52366CATHETER, PERCUTANEOUS5 reports
- Advance G44145CATHETER, PERCUTANEOUS4 reports
- Advance G18799Catheter, angioplasty, peripheral, transluminal4 reports
- Advance G30944Catheter, angioplasty, peripheral, transluminal4 reports
- Advance G30952Catheter, angioplasty, peripheral, transluminal4 reports
- Advance G30970Catheter, angioplasty, peripheral, transluminal4 reports
- Advance G34329Catheter, angioplasty, peripheral, transluminal4 reports
- Advance G34337Catheter, angioplasty, peripheral, transluminal4 reports
- Advance G34359Catheter, angioplasty, peripheral, transluminal4 reports
- Advance G34377Catheter, angioplasty, peripheral, transluminal4 reports
- Advance G50325Catheter, angioplasty, peripheral, transluminal4 reports
- Advance G50327Catheter, angioplasty, peripheral, transluminal4 reports
- Advance G50330Catheter, angioplasty, peripheral, transluminal4 reports
- Advance G50334Catheter, angioplasty, peripheral, transluminal4 reports
- Advance G50336Catheter, angioplasty, peripheral, transluminal4 reports
- Advance G52255CATHETER, PERCUTANEOUS4 reports
- Advance G52256CATHETER, PERCUTANEOUS4 reports
- Advance G52266CATHETER, PERCUTANEOUS4 reports
- Advance G52267CATHETER, PERCUTANEOUS4 reports
- Advance G52278CATHETER, PERCUTANEOUS4 reports
- Advance G52280CATHETER, PERCUTANEOUS4 reports
- Advance G52337CATHETER, PERCUTANEOUS4 reports
- Advance G52372CATHETER, PERCUTANEOUS4 reports
- Advance G52379CATHETER, PERCUTANEOUS4 reports
- Advance G30859Catheter, angioplasty, peripheral, transluminal3 reports
- Advance G34323Catheter, angioplasty, peripheral, transluminal3 reports
- Advance G34328Catheter, angioplasty, peripheral, transluminal3 reports
- Advance G34331Catheter, angioplasty, peripheral, transluminal3 reports
- Advance G34332Catheter, angioplasty, peripheral, transluminal3 reports
- Advance G34340Catheter, angioplasty, peripheral, transluminal3 reports
- Advance G34373Catheter, angioplasty, peripheral, transluminal3 reports
- Advance G50224CATHETER, PERCUTANEOUS3 reports
- Advance G50227CATHETER, PERCUTANEOUS3 reports
- Advance G50242CATHETER, PERCUTANEOUS3 reports
- Advance G50257CATHETER, PERCUTANEOUS3 reports
- Advance G50320Catheter, angioplasty, peripheral, transluminal3 reports
- Advance G50337Catheter, angioplasty, peripheral, transluminal3 reports
- Advance G50339Catheter, angioplasty, peripheral, transluminal3 reports
- Advance G52253CATHETER, PERCUTANEOUS3 reports
- Advance G52254CATHETER, PERCUTANEOUS3 reports
- Advance G52259CATHETER, PERCUTANEOUS3 reports
- Advance G52263CATHETER, PERCUTANEOUS3 reports
- Advance G52268CATHETER, PERCUTANEOUS3 reports
- Advance G52273CATHETER, PERCUTANEOUS3 reports
- Advance G52274CATHETER, PERCUTANEOUS3 reports
- Advance G52300CATHETER, PERCUTANEOUS3 reports
- Advance G52331CATHETER, PERCUTANEOUS3 reports
- Advance G52339CATHETER, PERCUTANEOUS3 reports
- Advance G52341CATHETER, PERCUTANEOUS3 reports
- Advance G52344CATHETER, PERCUTANEOUS3 reports
- Advance G52346CATHETER, PERCUTANEOUS3 reports
- Advance G26900CATHETER, PERCUTANEOUS2 reports
- Advance G26904CATHETER, PERCUTANEOUS2 reports
- Advance G30848Catheter, angioplasty, peripheral, transluminal2 reports
- Advance G30897Catheter, angioplasty, peripheral, transluminal2 reports
- Advance G30903Catheter, angioplasty, peripheral, transluminal2 reports
- Advance G30909Catheter, angioplasty, peripheral, transluminal2 reports
Recent Advance adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2025Crack; Crack
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 23098160 ↗MalfunctionJan 23, 2025Material Separation; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED 27JAN2025 FROM THE CUSTOMER AND 20FEB2025 VIA A MEDWATCH REPORT SUBMITTED BY THE CUSTOMER. THE PROCEDURE INVOLVED AN AORTOGRAM, BILATERAL LOWER EXTREMITY ANGIOGRAMS, BALLOON ANGIOPLASTY OF THE RIGHT POPLITEAL ARTERY, AND REVASCULARIZATION OF THE LEFT LEG WITH ANGIOPLASTY FROM THE TIBIOPERONEAL TRUNK INTO THE POPLITEAL ARTERY, VIA LEFT FEMORAL ACCESS. ANOTHER MANUFACTURER¿S 6-FRENCH, 90-CENTIMETER SHEATH WAS USED DURING THE PROCEDURE. THE ANATOMY WAS STENOSED, AND THE LESION WITHIN THE POPLITEAL ARTERY WAS 100% OCCLUDED. ANOTHER MANUFACTURER¿S INFLATION DEVICE WAS USED TO INFLATE THE BALLOON TO APPROXIMATELY 12-TO-14 ATMOSPHERES WITHIN THE RIGHT TIBIOPERONEAL TRUNK AND PERONEAL ARTERY. AS THE BALLOON WAS INFLATED, THE USER NOTED MARKED OCCLUSIVE DISEASE IN THE TIBIOPERONEAL TRUNK, WHICH, PER THE REPORTER, RUPTURED THE BALLOON CIRCUMFERENTIALLY, BELOW THE RATED BURST PRESSURE, AS PRESSURE WAS RELEASED. AFTER ANGIOPLASTY, MINIMAL FLOW ¿INTO THE SEGMENTS¿ WAS REPORTED WITH BALLOON RUPTURE AND FRAGMENTATION. THE BALLOON WAS NOT INFLATED WITHIN A STENT. BLOOD WAS NOTED IN THE INFLATION DEVICE UPON DEFLATION. THE BALLOON WAS ALLOWED TO RETURN TO AMBIENT
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21220119 ↗MalfunctionDec 27, 2024Material Rupture; Material Rupture
AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE OF A LOWER EXTREMITY, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER¿S BALLOON RUPTURED. THE PATIENT¿S ANATOMY WAS MODERATELY CALCIFIED. AN UNKNOWN COOK 5-FRENCH SHEATH WAS USED DURING THE PROCEDURE. AN UNSPECIFIED INFLATION DEVICE WAS USED TO INFLATE THE BALLOON ONE TIME WITHIN A LESION IN THE SUPERFICIAL FEMORAL/COMMON FEMORAL ARTERY; HOWEVER, THE BALLOON RUPTURED WITHIN FIFTEEN SECONDS, AT SIX ATMOSPHERES. THE BALLOON WAS NOT INFLATED WITHIN A STENT, AND BLOOD WAS NOTED IN THE INFLATION DEVICE UPON RUPTURE. THE BALLOON WAS ALLOWED TO RETURN TO AMBIENT PRESSURE, AND NEGATIVE PRESSURE WAS MAINTAINED UPON REMOVAL OF THE BALLOON CATHETER, WHICH WAS REMOVED BY ITSELF. ANOTHER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED, DID NOT REQUIRE ANY ADDITIONAL PROCEDURES, AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21027170 ↗MalfunctionDec 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING A PERIPHERAL ANGIOPLASTY PROCEDURE VIA A CONTRALATERAL APPROACH, THE HUB SEPARATED FROM AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER. A TWENTY-MILLILITER SYRINGE WAS USED TO FLUSH THE DEVICE DURING PREPARATION. PER THE REPORTER, MULTIPLE CATHETERS AND BALLOONS USED DURING THE PROCEDURE WERE DIFFICULT TO TRACK THROUGH ANOTHER MANUFACTURER¿S SHEATH, OVER AN UNSPECIFIED ROSEN WIRE GUIDE. THE COMPLAINT DEVICE WAS DIFFICULT TO ADVANCE UP AND OVER A TIGHT BIFURCATION, THROUGH THE OTHER MANUFACTURER¿S SHEATH. PER THE REPORTER, THE PHYSICIAN MENTIONED THAT THE OTHER MANUFACTURER¿S SHEATH MIGHT HAVE MIGRATED INTO THE AORTA, MAKING THE ¿BEND¿ MORE ACUTE. AFTER THE BALLOON WAS USED, ¿A LOT OF¿ RESISTANCE WAS ENCOUNTERED UPON ATTEMPTED REMOVAL OF THE DEVICE OVER A WIRE GUIDE. WITH THE USE OF FORCE TO PULL THE CATHETER, THE HUB SEPARATED. THE BALLOON CATHETER WAS THEN REMOVED WITH THE WIRE GUIDE AS A UNIT, AT WHICH POINT THE USER NOTED THAT THE CATHETER WAS STRETCHED BUT OTHERWISE INTACT. PER THE REPORTER, THE PHYSICIAN ¿DOES NOT THINK THE BALLOON CATHETER WAS THE ISSUE.¿ THE OTHER MANUFACTURER¿S SHEATH WAS EXCHANGED FOR ANOTHER DEVICE, AFTER WHICH THE SURGEON REPORTEDLY FO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21020585 ↗InjuryDec 5, 2024Material Rupture; Material Rupture
ADDITIONAL INFORMATION WAS RECEIVED 11DEC2024. THE BALLOON WAS INFLATED ONE TIME BEFORE RUPTURING CIRCUMFERENTIALLY AT NINE ATMOSPHERES, AT WHICH POINT BLOOD WAS ASPIRATED INTO THE INFLATION DEVICE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. UPON ATTEMPTED REMOVAL OF THE DEVICE, USING A COUNTERCLOCKWISE ROTATION OF THE CATHETER, THE BALLOON MATERIAL SEPARATED FROM THE CATHETER. BECAUSE THE BALLOON HAD RUPTURED, NEGATIVE PRESSURE COULD NOT BE ADEQUATELY ACHIEVED DURING REMOVAL. THE SEPARATED BALLOON MATERIAL WAS SUCCESSFULLY REMOVED AT AN OUTSIDE FACILITY.
Patient problems: Foreign Body In Patient
MAUDE report 20858403 ↗MalfunctionDec 3, 2024Break; Break
AS REPORTED, DURING A PROCEDURE INVOLVING BALLOON DILATION OF A STENOSED ILIAC VEIN, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER SEPARATED. THE ANATOMY WAS REPORTEDLY SLIGHTLY STENOSED. A COOK 10-FRENCH SHEATH WAS ALSO USED DURING THE PROCEDURE. PER THE REPORTER, AN UNSPECIFIED INFLATION DEVICE WAS USED TO INFLATE THE BALLOON TO FIVE ATMOSPHERES. THE BALLOON WAS INFLATED TWO TIMES, FOR TWO MINUTES EACH TIME, TO GRADUALLY DILATE THE LESION, WHICH WAS REPORTEDLY SEVENTY PERCENT OCCLUDED. DURING DILATION, THE BALLOON CATHETER SUDDENLY ¿BROKE¿ WITHIN THE VESSEL. THE USER IS REPORTEDLY UNSURE IF THE BALLOON RUPTURED PRIOR TO SEPARATION OF THE CATHETER; HOWEVER, BLOOD WAS NOT NOTED IN THE INFLATION DEVICE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. ONCE DEFLATED, THE BALLOON WAS ALLOWED TO RETURN TO AMBIENT PRESSURE, AND NEGATIVE PRESSURE WAS MAINTAINED UPON ATTEMPTED REMOVAL OF THE DEVICE. THE USER ATTEMPTED TO REMOVE THE BALLOON CATHETER AND SHEATH AS A UNIT. A COUNTERCLOCKWISE ROTATION OF THE BALLOON WAS NOT CONDUCTED UPON REMOVAL. THE SEPARATED CATHETER FRAGMENTS WERE SUCCESSFULLY REMOVED WITH AN UNSPECIFIED FILTER RETRIEVAL DEVICE, VIA A JUGULAR APPROACH TO THE INFERIOR VENA CAV
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20835847 ↗InjuryNov 26, 2024Material Rupture; Material Rupture
AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY OF A STENOTIC SUBCLAVIAN VEIN AND BRACHIAL FISTULA, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED CIRCUMFERENTIALLY AND SUBSEQUENTLY SEPARATED. THE DEVICE WAS USED ONE TIME. PER THE REPORTER, AFTER THE BALLOON RUPTURED, HALF OF THE BALLOON MATERIAL SEPARATED/DISLODGED AND MIGRATED TO THE PATIENT'S LUNG, WHERE IT IS LODGED. REPORTEDLY, THE SEPARATED FRAGMENT CANNOT BE RETRIEVED AND WILL BE LEFT IN THE LUNG. NO ADDITIONAL ADVERSE EVENTS HAVE BEEN REPORTED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE, A PORTION OF THE BALLOON WAS MISSING, AND THE SHAFT WAS SEPARATED.
Patient problems: Foreign Body In Patient
MAUDE report 20784202 ↗MalfunctionNov 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE BETWEEN THE PORTAL VEIN AND INFERIOR VENA CAVA, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER¿S BALLOON LEAKED. THE ANATOMY WAS STENOSED, TORTUOUS, AND/OR CALCIFIED. A 10-FRENCH COOK SHEATH WAS USED DURING THE PROCEDURE. A COOK CONTRAST CATHETER WAS INSERTED INTO ABNORMAL ESOPHAGEAL VARICES AND EMBOLIC GELATIN SPONGE PARTICLES WERE SLOWLY INJECTED. THE COMPLAINT DEVICE WAS THEN ADVANCED OVER A WIRE GUIDE. THE BALLOON WAS INFLATED TO SIX ATMOSPHERES ONE TIME; HOWEVER, THE BALLOON LEAKED, AND BLOOD WAS NOTED IN THE INFLATION DEVICE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. THE BALLOON CATHETER WAS REMOVED, AND 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 OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. THE INITIAL EVALUATION OF THE RETURNED/USED DEVICE, RECEIVED ON 31OCT2024, INDICATES THE BALLOON LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20605109 ↗MalfunctionNov 4, 2024Material 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 20604007 ↗MalfunctionOct 30, 2024Break; Break
AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED. THE BALLOON REPORTEDLY RUPTURED AFTER INFLATION "EVEN RESPECTING THE PRESSURE LIMIT, AFTER FLARE INSIDE THE STENT." THE BALLOON AND CATHETER TIP THEN SEPARATED IN THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20570737 ↗InjuryOct 28, 2024Material Rupture; Material Rupture
AS REPORTED, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED DURING AN UNKNOWN PROCEDURE. UPON RELEASE OF THE INFLATION DEVICE, THE USER NOTED THAT THE BALLOON HAD RUPTURED, AS BLOOD WAS COMING BACK THROUGH THE CATHETER. THE PHYSICIAN INITIALLY BELIEVED THAT THE BALLOON WAS FULLY REMOVED FROM THE PATIENT; HOWEVER, UPON CLOSER INSPECTION AND ADMINISTRATION OF CONTRAST UNDER FLUOROSCOPY, THE PHYSICIAN DISCOVERED THAT PART OF THE BALLOON AND RADIOPAQUE MARKER REMAINED IN THE PATIENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE FRAGMENT FROM THE PATIENT; HOWEVER, THIS WAS UNSUCCESSFUL AND THEREFORE, THE RETAINED FRAGMENT WAS STENTED TO THE WALL OF THE SUPERFICIAL FEMORAL ARTERY.
Patient problems: Foreign Body In Patient
MAUDE report 20544212 ↗MalfunctionOct 4, 2024Material 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 20367967 ↗MalfunctionSep 6, 2024Material 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 20163020 ↗MalfunctionAug 27, 2024Material Rupture; Material Rupture
AS REPORTED, DURING AN INTERVENTIONAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE WITHIN CHRONIC TOTAL OCCLUSIONS OF THE LEFT SUPERFICIAL FEMORAL AND LEFT POSTERIOR TIBIAL ARTERIES, TWO ADVANCE 18 LP LOW PROFILE BALLOON CATHETERS¿ BALLOONS RUPTURED. ACCESS WAS OBTAINED IN THE LEFT POSTERIOR TIBIAL ARTERY. PER THE REPORTER, A PRE-EXISTING STENT CAUSED THE BALLOONS TO RUPTURE. AN UNSPECIFIED ¿1.5 LASER¿ WAS USED DURING THE PROCEDURE, AS WELL AS A COOK CATHETER, WIRE GUIDES, AND STENT. REPORTEDLY, ANOTHER ADVANCE 18 LP LOW PROFILE BALLOON CATHETER¿S BALLOON FROM A DIFFERENT LOT ALSO RUPTURED DURING THE PROCEDURE. THAT EVENT WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6). ANOTHER BALLOON OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE, AND AN 8X80 STENT WAS PLACED. 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 20078889 ↗MalfunctionAug 27, 2024Material Rupture; Material Rupture
AS REPORTED, DURING AN INTERVENTIONAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE WITHIN CHRONIC TOTAL OCCLUSIONS OF THE LEFT SUPERFICIAL FEMORAL AND LEFT POSTERIOR TIBIAL ARTERIES, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER¿S BALLOON RUPTURED. ACCESS WAS OBTAINED IN THE LEFT POSTERIOR TIBIAL ARTERY. PER THE REPORTER, A PRE-EXISTING STENT CAUSED THE BALLOON TO RUPTURE. AN UNSPECIFIED ¿1.5 LASER¿ WAS USED DURING THE PROCEDURE, AS WELL AS A COOK CATHETER, WIRE GUIDES, AND STENT. REPORTEDLY, TWO OTHER ADVANCE 18 LP LOW PROFILE BALLOON CATHETERS¿ BALLOONS FROM A DIFFERENT LOT ALSO RUPTURED DURING THE PROCEDURE. THAT EVENT WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6). ANOTHER BALLOON OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE, AND AN 8X80 STENT WAS PLACED. 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 20078862 ↗
Other Cook Incorporated products
- Torcon NB79 models · 36 reports · 68 recalls
- Flexor134 models · 1,437 reports · 3 recalls
- Instinct5 models · 1,289 reports · 1 recall
- Saeed15 models · 863 reports
- Gunther Tulip5 models · 807 reports
- Hemospray2 models · 535 reports · 4 recalls
- NCircle10 models · 725 reports
- Roadrunner28 models · 183 reports · 9 recalls
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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