POWERFLEXRecalls & reported problems across all models
Cordis US Corp. · 56 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 306
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 0
We found 56 models of POWERFLEX by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 306 adverse event reports in the FDA's MAUDE database, received between Nov 4, 2016 and Dec 26, 2025 — classified as 16 injuries, 290 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (222 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 POWERFLEX problems
Device problems
- Burst Container or Vessel222
- Leak/Splash55
- Detachment of Device or Device Component12
- Material Rupture7
- Difficult to Remove6
- Detachment Of Device Component3
- Device Contaminated During Manufacture or Shipping3
- Difficult to Advance3
Patient problems
- No Consequences Or Impact To Patient164
- No Clinical Signs, Symptoms or Conditions132
- No Known Impact Or Consequence To Patient6
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- Insufficient Information1
- No Code Available1
- Obstruction/Occlusion1
POWERFLEX models
56 models, most reported first. Each model has its own page with its reports, recalls and device details.
- POWERFLEX 4156040SCATHETER, PERCUTANEOUS45 reports
- POWERFLEX 4400804SCatheter, angioplasty, peripheral, transluminal25 reports
- POWERFLEX 4400504SCatheter, angioplasty, peripheral, transluminal20 reports
- POWERFLEX 4400704SCatheter, angioplasty, peripheral, transluminal20 reports
- POWERFLEX 4401004SCatheter, angioplasty, peripheral, transluminal18 reports
- POWERFLEX 4158040SCATHETER, PERCUTANEOUS13 reports
- POWERFLEX 4400704XCatheter, angioplasty, peripheral, transluminal13 reports
- POWERFLEX 4400804XCatheter, angioplasty, peripheral, transluminal13 reports
- POWERFLEX 4400404SCatheter, angioplasty, peripheral, transluminal10 reports
- POWERFLEX 4204040TCATHETER, PERCUTANEOUS9 reports
- POWERFLEX 4206040SCATHETER, PERCUTANEOUS9 reports
- POWERFLEX 4202040SCATHETER, PERCUTANEOUS8 reports
- POWERFLEX 4401004XCatheter, angioplasty, peripheral, transluminal7 reports
- POWERFLEX 4401204SCatheter, angioplasty, peripheral, transluminal7 reports
- POWERFLEX 4400504XCatheter, angioplasty, peripheral, transluminal6 reports
- POWERFLEX 4400404XCatheter, angioplasty, peripheral, transluminal5 reports
- POWERFLEX 4400610SCatheter, angioplasty, peripheral, transluminal5 reports
- POWERFLEX 4401002SCatheter, angioplasty, peripheral, transluminal5 reports
- POWERFLEX 4400415XCatheter, angioplasty, peripheral, transluminal4 reports
- POWERFLEX 4400502SCatheter, angioplasty, peripheral, transluminal4 reports
- POWERFLEX 4400610XCatheter, angioplasty, peripheral, transluminal4 reports
- POWERFLEX 4400304XCatheter, angioplasty, peripheral, transluminal3 reports
- POWERFLEX 4400515XCatheter, angioplasty, peripheral, transluminal3 reports
- POWERFLEX 4400802XCatheter, angioplasty, peripheral, transluminal3 reports
- POWERFLEX 4400808XCatheter, angioplasty, peripheral, transluminal3 reports
- POWERFLEX 4401206SCatheter, angioplasty, peripheral, transluminal3 reports
- POWERFLEX 4156040TCATHETER, PERCUTANEOUS2 reports
- POWERFLEX 4205040SCATHETER, PERCUTANEOUS2 reports
- POWERFLEX 4206040TCATHETER, PERCUTANEOUS2 reports
- POWERFLEX 4209040SCATHETER, PERCUTANEOUS2 reports
- POWERFLEX 4400422XCatheter, angioplasty, peripheral, transluminal2 reports
- POWERFLEX 4400506XCatheter, angioplasty, peripheral, transluminal2 reports
- POWERFLEX 4400522XCatheter, angioplasty, peripheral, transluminal2 reports
- POWERFLEX 4400606XCatheter, angioplasty, peripheral, transluminal2 reports
- POWERFLEX 4400608XCatheter, angioplasty, peripheral, transluminal2 reports
- POWERFLEX 4400806XCatheter, angioplasty, peripheral, transluminal2 reports
- POWERFLEX 4400902SCatheter, angioplasty, peripheral, transluminal2 reports
- POWERFLEX 4150040SCATHETER, PERCUTANEOUS1 report
- POWERFLEX 4154040SCATHETER, PERCUTANEOUS1 report
- POWERFLEX 4205020TCATHETER, PERCUTANEOUS1 report
- POWERFLEX 4206080SCATHETER, PERCUTANEOUS1 report
- POWERFLEX 4207000SCATHETER, PERCUTANEOUS1 report
- POWERFLEX 4400308XCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400310XCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400322XCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400402SCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400408XCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400412XCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400502XCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400602XCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400615SCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400622SCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400806SCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400902XCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4401202SCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4401204XCatheter, angioplasty, peripheral, transluminal1 report
Recent POWERFLEX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 26, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON ON A 4MM X 4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED ON ITS FIRST INFLATION. A NON-CORDIS DEVICE WAS USED AS A REPLACEMENT, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS USED FOR PRE-DILATION AT THE EXTERNAL ILIAC ARTERY (EIA) WHICH HAD A CHRONIC TOTAL OCCLUSION (CTO). THE TARGET SITE VESSEL WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS WITH 100% STENOSIS. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS NOT PUT INTO AN ACUTE BEND AT ANY POINT DURING THE PROCEDURE AND WAS NOT ABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED EASILY AND INTACT IN ONE PIECE FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23898543 ↗MalfunctionAug 5, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 4MM X 15CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING THE PROCEDURE. THE DEVICE WAS NOT AVAILABLE AND THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PTA PROCEDURE. THE TARGET VESSEL WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET SITE VESSEL CHARACTERISTICS INCLUDED MILD TORTUOSITY AND 70% STENOSIS WITH NO SIGNS OF CALCIFICATION. THE DEVICE WAS STORED, PREPARED, AND USED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DAMAGE TO THE DEVICE OR DEVICE PACKAGING PRIOR TO USE. THE PHYSICIAN ACHIEVED CERTIFICATION ON THE USE OF THE POWERFLEX PRO BALLOON CATHETER AND HAS USED THE DEVICE SEVERAL TIMES PRIOR TO THIS PROCEDURE. THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE CONTRAST TO SALINE RATIO USED WAS 1:1. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22715790 ↗MalfunctionJun 27, 2025Leak/Splash; Leak/Splash
AS REPORTED, CONTRAST APPEARED TO LEAK OUT THE BACK OF A 6MM X 4CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, ON THE SIDE OF AN UNKNOWN SHEATH. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345627 ↗MalfunctionApr 17, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 5MM X 4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 6 ATMOSPHERES (ATM). AN UNKNOWN DEVICE WAS USED AS A REPLACEMENT WITHOUT ISSUE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) LESION. A NON-CORDIS GUIDEWIRE WAS USED DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21854267 ↗MalfunctionMar 28, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, A 4MM X 4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 6 ATMOSPHERES (ATM). AN UNKNOWN DEVICE WAS USED AS A REPLACEMENT AND WAS INFLATED WITHOUT ISSUE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) LESION, A NON-CORDIS .035 GUIDEWIRE WAS INSERTED ACROSS THE LESION PRIOR TO THE USE OF THE POWERFLEX PRO PTA BALLOON CATHETER. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21720648 ↗MalfunctionDec 2, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF THE 5MM 4CMPOWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DEVICE RUPTURED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER POWERFLEX PRO BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE LESION WAS MINIMALLY CALCIFIED, AND THE VESSEL TORTUOSITY WAS ALSO MINIMAL. THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. ADDITIONALLY, THERE WERE NO ISSUES ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE BALLOON CATHETER DID NOT KINK DURING USE, AND IT WAS REMOVED INTACT FROM THE PATIENT. IT WILL BE RETURNED FOR FURTHER ANALYSIS AND EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20819067 ↗InjuryJun 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THE CONNECTION BETWEEN THE DISTAL TIP AND THE BALLOON 8MM 4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON FRACTURED INSIDE OF THE PATIENT DURING USE. A SNARE WAS USED TO REMOVE THE SEPARATED PIECE. THE PROCEDURE WAS COMPLETED WITH ANOTHER POWERFLEX PRO DEVICE. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE TARGET LESION WAS AN ARTERIOSCLEROSIS OF THE LOWER LIMBS. DELUSION WAS NOTED TO HAVE MODERATE CALCIFICATION. THE VESSEL HAD MODERATE TORTUOSITY. THE LESION HAD A 70% STENOSIS. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION. THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE DEVICE THROUGH THE ROTATING HEMOSTATIC VALVE. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE BALLOON CATHETER DID HAVE A MILD KINK WHILE BEING USED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS MULTIPLE A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19640606 ↗MalfunctionApr 24, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 5MM 2CM POWERFLEX PRO RUPTURED BEFORE NOMINAL PRESSURE WAS REACHED. AFTER THAT, IT WAS EXPANDED WITH THE SAME SIZE BALLOON, AND THE PROCEDURE WAS COMPLETED BY SMART STENT PLACEMENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION COULD NOT BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19174247 ↗MalfunctionApr 7, 2024Leak/Splash; Leak/Splash
AS REPORTED, THE BALLOON OF A 4MM8CM 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATION CATHETER WAS FOUND TO HAVE A HOLE WHEN BEING INFLATED. THE BALLOON WAS CAUGHT IN THE LESION, AND ABLE TO BE REMOVED INTACT EASILY FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE HOLE WAS FOUND JUST AS THE DEVICE WAS INFLATED. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION FOR 4 SECONDS. THE DEVICE WAS INFLATED TO 8 ATMOSPHERES BEFORE THE ANOMALY WAS NOTED. THERE WERE NO VISIBLE SIGNS OF DEVICE OR PACKAGE DAMAGE PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, OR ANY OF THE STERILE PACKAGING COMPONENTS. THE GAUGE OF THE INDEFLATOR INDICATED A LOSS OF PRESSURE WHEN THE ANOMALY WAS NOTED. A CONTRALATERAL APPROACH WAS USED. THE TARGET VESSEL WAS THE SUPERFICIAL FEMORAL ARTERY. THE TARGET VESSEL SITE HAD MILD CALCIFICATION AND TORTUOSITY. THERE WAS 35% STENOSIS AND THERE WAS NO ACUTE ANGLE OR BIFURCATION. THE DEVICE WAS NO PUT INTO AN ACUTE BEND AT ANY POINT DURING THE PROCEDURE. THE DEVICE WAS ABLE TO CROSS THE LESION. THE DEVICE DID NOT KINK AT ANY TIME DURIN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19056912 ↗MalfunctionMar 18, 2024Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove
AS REPORTED, A 10MM 4CM POWERFLEX PRO PTA BURST IN AN ILIAC ARTERY, AND IT GOT STUCK IN THE 6F CORDIS BRITE TIP RADIANZ. THE BALLOON WAS NOTED TO HAVE BURST/ RUPTURED AT 6ATM. A NEW BRITE TIP RADIANZ WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. A 6F CORDIS BRITE TIP SHEATH WAS USED DURING THE PROCEDURE. THE LESION WAS NOTED TO HAVE SEVERE CALCIFICATION WITH LITTLE VESSEL TORTUOSITY. THE LESION WAS NOTED TO HAVE AN 85% STENOSIS. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE UNKNOWN GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON THROUGH THE VESSEL. T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18924306 ↗MalfunctionMar 8, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF AN 8MM X 4CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 15 ATMOSPHERES (ATM). A SECOND 8MM X 40MM POWERFLEX EXTREME PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A GREATER THAN 70% STENOSED FISTULA LESION WHICH HAD MODERATE CALCIFICATION BUT NO SIGNS OF TORTUOSITY. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. AN 80% SALINE AND 20% CONTRAST MIXTURE WAS USED TO PREP THE DEVICE. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865203 ↗MalfunctionMar 8, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 6MM X 4CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 20 ATMOSPHERES (ATM). A SECOND 6MM X 40MM POWERFLEX EXTREME PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865062 ↗MalfunctionFeb 14, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
AS REPORTED, THE 4MM 4CM POWERFLEX PRO BALLOON WAS NOT PACKAGED ASEPTICALLY. AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE PLASTIC ASEPTIC PACKAGE INSIDE WAS NOT SEALED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18702401 ↗MalfunctionJan 16, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 5MM X 4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED BEFORE REACHING ITS RATED BURST PRESSURE. THE DEVICE WAS REPLACED WITH A NEW 5MM X 4CM POWERFLEX PRO PTA BALLOON CATHETER TO COMPETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 90% STENOSED ILIAC LESION WHICH HAD MILD CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THE INITIAL POWERFLEX PRO PTA BALLOON CATHETER WAS INFLATED AND DEFLATED SEVERAL TIMES PRIOR TO THE BALLOON RUPTURE. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAIN IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18519991 ↗MalfunctionJan 12, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 5MM 4CM POWERFLEX PRO WAS USED TOGETHER WITH A NON-CORDIS GUIDEWIRE BUT RUPTURED BEFORE THE PRESSURE REACHES ITS NOMINAL PRESSURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS A PTA CASE. THE LESION WAS THE POPLITEAL ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18503462 ↗
Other Cordis US Corp. products
- MYNXGRIP2 models · 2,276 reports · 2 recalls
- Cordis ExoSeal Vascular Closure Device3 models · 1,279 reports
- MYNX CONTROL2 models · 534 reports
- SABER51 models · 270 reports
- Cordis S.M.A.R.T. Control Vascular Stent System30 models · 99 reports · 2 recalls
- INFINITI20 models · 107 reports
- AVIATOR19 models · 75 reports
- AVANTI11 models · 70 reports
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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