POWERFLEXRecalls & reported problems across all models
Cordis Corporation · 34 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 151
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 34 models of POWERFLEX by Cordis Corporation in the FDA's device registry (GUDID). Together they are named in 151 adverse event reports in the FDA's MAUDE database, received between Nov 7, 2016 and Mar 7, 2025 — classified as 2 injuries, 149 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (94 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 Vessel94
- Leak/Splash40
- Device Contaminated During Manufacture or Shipping6
- Difficult to Remove6
- Detachment of Device or Device Component3
- Deflation Problem2
- Material Frayed2
- Material Split, Cut or Torn2
Patient problems
- No Consequences Or Impact To Patient77
- No Clinical Signs, Symptoms or Conditions73
- No Known Impact Or Consequence To Patient1
POWERFLEX models
34 models, most reported first. Each model has its own page with its reports, recalls and device details.
- POWERFLEX 4155040SCATHETER, PERCUTANEOUS21 reports
- POWERFLEX 4157040SCATHETER, PERCUTANEOUS14 reports
- POWERFLEX 4400604SCatheter, angioplasty, peripheral, transluminal10 reports
- POWERFLEX 4400802SCatheter, angioplasty, peripheral, transluminal10 reports
- POWERFLEX 4401206XCatheter, angioplasty, peripheral, transluminal9 reports
- POWERFLEX 4400604XCatheter, angioplasty, peripheral, transluminal8 reports
- POWERFLEX 4400615XCatheter, angioplasty, peripheral, transluminal8 reports
- POWERFLEX 4400622XCatheter, angioplasty, peripheral, transluminal7 reports
- POWERFLEX 4205040TCATHETER, PERCUTANEOUS6 reports
- POWERFLEX 4400904SCatheter, angioplasty, peripheral, transluminal6 reports
- POWERFLEX 4158060SCATHETER, PERCUTANEOUS5 reports
- POWERFLEX 4150060SCATHETER, PERCUTANEOUS4 reports
- POWERFLEX 4400602SCatheter, angioplasty, peripheral, transluminal4 reports
- POWERFLEX 4400702SCatheter, angioplasty, peripheral, transluminal4 reports
- POWERFLEX 4159040SCATHETER, PERCUTANEOUS3 reports
- POWERFLEX 4400410XCatheter, angioplasty, peripheral, transluminal3 reports
- POWERFLEX 4400702XCatheter, angioplasty, peripheral, transluminal3 reports
- POWERFLEX 4400904XCatheter, angioplasty, peripheral, transluminal3 reports
- POWERFLEX 4204040SCATHETER, PERCUTANEOUS2 reports
- POWERFLEX 4400315XCatheter, angioplasty, peripheral, transluminal2 reports
- POWERFLEX 4400506SCatheter, angioplasty, peripheral, transluminal2 reports
- POWERFLEX 4400508SCatheter, angioplasty, peripheral, transluminal2 reports
- POWERFLEX 4400510XCatheter, angioplasty, peripheral, transluminal2 reports
- POWERFLEX 4401008XCatheter, angioplasty, peripheral, transluminal2 reports
- POWERFLEX 4401010XCatheter, angioplasty, peripheral, transluminal2 reports
- POWERFLEX 4200080SCATHETER, PERCUTANEOUS1 report
- POWERFLEX 4204020TCATHETER, PERCUTANEOUS1 report
- POWERFLEX 4400510SCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400612XCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400708SCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400708XCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400710SCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4400710XCatheter, angioplasty, peripheral, transluminal1 report
- POWERFLEX 4401006XCatheter, 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.
MalfunctionMar 7, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 7MM X 4CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AS 20 ATMOSPHERES (ATM). THE BALLOON WAS REMOVED FULL INTACT AND A NEW 7MM X 4CM 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 AN ARTERIAL ANASTOMOSIS STENOSIS WHICH WAS NOT CALCIFIED OR TORTUOUS AND HAD A STENOSIS PERCENTAGE GREATER THAN 80%. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE CONTRAST TO SALINE RATIO WAS 50 SALINE/50 CONTRAST. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21547915 ↗MalfunctionJun 17, 2024Leak/Splash; Leak/Splash
AS REPORTED, A 12MM 6CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON LEAKED DURING USE. IT WAS ALSO NOTED THAT THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THE CASE WAS COMPLETED WITH A NEW CORDIS 12X60 BALLOON. 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, 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 LESION WAS NOTED TO HAVE MODERATE CALCIFICATION. THE VESSEL WAS NOTED TO HAVE MODERATE TORTUOSITY. THE LESION HAD A 50% 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. THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE BALLOON THROUGH THE UNKNOWN GUIDE CATHETER. THE CATHETER WAS NEVER IN AN ACUTE BEND AND WAS NEVER KINKED DURING USE. THE SALINE/CONTRAST RATIO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19552863 ↗MalfunctionMay 8, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 6MM 4CM POWERFLEX PRO WAS USED. HOWEVER, IT RUPTURED WITHIN ITS NOMINAL PRESSURE. THEREFORE, IT WAS REPLACED WITH A NEW BALLOON CATHETER (NON-CORDIS) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS A PTA CASE. THE LESION WAS THE COMMON FEMORAL ARTERY. AN .035 NON-CORDIS GUIDEWIRE CROSSED THE LESION. THE DEVICE WILL 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 19270889 ↗MalfunctionApr 24, 2024Material Frayed; Structural Problem; Material Split, Cut or Torn; Material Frayed; Structural Problem; Material Split, Cut or Torn
AS REPORTED, THE 12MM 6CM POWERFLEX BALLOON WAS PUMPED TO THE RATED BURST PRESSURE BUT COULD NOT FILL PROPERLY, AND CONTINUED TO INCREASE THE PRESSURE AND STILL COULD NOT FILL. THE BALLOON WAS CHANGED TO A NON-CORDIS BALLOON, WITH THE SAME PRESSURE PUMP. THE BALLOON COULD FILL NORMALLY. IT WAS SUSPECTED THAT THE BALLOON WAS DAMAGED, OR THE FILLING CHAMBER WAS BLOCKED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS OCCURRED DURING AN ILIAC VEIN COMPRESSION SURGERY. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS. THE PRODUCT EVALUATION SHOWED THE BALLOON WAS FRAYED/SPLIT AND MARKERBAND-OUT OF POSITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175821 ↗MalfunctionMar 18, 2024Leak/Splash; Leak/Splash
AS REPORTED, THE BALLOON OF A 10MM X 8CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WOULD NOT INFLATE PAST 14 ATMOSPHERES (ATM). AFTER REMOVING THE BALLOON FROM THE PATIENT, A LEAKAGE AROUND THE TIP OF THE BALLOON WAS OBSERVED. A NON-CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. AN UNKNOWN 7F CATHETER SHEATH INTRODUCER (CSI) WAS USED DURING THIS PROCEDURE. THE POWERFLEX P3 PTA BALLOON CATHETER WAS INSERTED OVER AN UNKNOWN .035 GLIDE WIRE. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED WITH A 5CC CONTRAST AND 12CC SALINE MIXTURE. AN UNKNOWN 7F CORDIS SHEATH WAS USED FOR ACCESS. A NON-CORDIS GUIDEWIRE WAS USED FOR THIS PROCEDURE. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WAS NOT RETURNED AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18927027 ↗MalfunctionMar 13, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 6MM X 15CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT WORKING PRESSURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18896979 ↗MalfunctionDec 1, 2023Deflation Problem; Deflation Problem
AS REPORTED, THE INFLATION OF A 6MM X 4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS REMARKABLY SLOW. AS A RESULT, THE DEVICE WAS DEFLATED AND REMOVED; HOWEVER, THE DEFLATION OF THE DEVICE WAS REMARKABLY SLOW AS WELL. THE DEVICE WAS REPLACED WITH A 6MM X 4CM SABERX PTA BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AND ENDOVASCULAR THERAPY (EVT) PROCEDURE TO TREAT A 90% STENOSED SUPERFICIAL FEMORAL ARTERY (SFA) LESION WHICH HAD MILD CALCIFICATION AND MILD TORTUOSITY. THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. A NON-CORDIS GUIDEWIRE WAS USED, AND THE POWERFLEX PRO PTA BALLOON CATHETER WAS ADVANCED ALONG THE NON-CORDIS GUIDEWIRE PRIOR TO ITS ATTEMPTED INFLATION. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES (ATM) VIA AN UNKNOWN INFLATION DEVICE AND WAS ABLE TO BE FULLY DEFLATED PRIOR TO ITS REMOVAL. THE DEVICE REMAINED IN ONE PIECE DURING ITS REMOVAL FROM THE PATIENT. THE DEVIC
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18245234 ↗MalfunctionSep 1, 2023Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 6MM X 20MM 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED PRIOR TO REACHING ITS NOMINAL PRESSURE DURING A PRE-DILATION INFLATION. AS A RESULT, AN UNKNOWN BALLOON CATHETER WAS USED TO CONTINUE THE PROCEDURE AND A NON-CORDIS STENT WAS IMPLANTED. THE UNKNOWN BALLOON CATHETER WAS USED FOR POST-DILATION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN INTERVENTIONAL PROCEDURE TO TREAT A LESION IN THE ILIAC ARTERY. AN IPSILATERAL RETROGRADE APPROACH WAS USED FOR THIS PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE. THE DEVICE HAS NOW BEEN RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17669580 ↗MalfunctionAug 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, THE FACILITY RECEIVED 10 POWERFLEX PRO BALLOONS (MULTIPLE SIZES) THAT WERE CONTAMINATED WITH DIRT PARTICLES EITHER IN BOX AND OR PACKAGING. FOR FEAR OF CONTAMINATING STERILE FIELD, TWO OF THESE BALLOONS THAT WERE GOING TO BE USED DID NOT GET OPENED BECAUSE PROCEDURAL PERSON NOTICED THE DIRT PRIOR TO OPENING. UPON FURTHER INSPECTION OF REMAINING BALLOONS, THEY DISCOVERED THAT AN ADDITIONAL 8 BALLOONS WERE SIMILARLY CONTAMINATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT IS UNKNOWN IF THE DIRT PARTICLES WERE WITHIN THE SEALED PORTION OF THE PACKAGES. THE FACILITY DOES NOT HAVE A RECEIVING BAY. THE DEVICES WERE STORED FOR APPROXIMATELY ONE MONTH PRIOR TO USE. THERE WERE NO DAMAGES NOTED TO THE SHIPPING BOXES. THERE WAS NO DAMAGE NOTED TO THE ACTUAL DEVICE PACKAGING. THE DEVICES WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17639019 ↗MalfunctionAug 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, THE FACILITY RECEIVED 10 POWERFLEX PRO BALLOONS (MULTIPLE SIZES) THAT WERE CONTAMINATED WITH DIRT PARTICLES EITHER IN BOX AND OR PACKAGING. FOR FEAR OF CONTAMINATING STERILE FIELD, TWO OF THESE BALLOONS THAT WERE GOING TO BE USED DID NOT GET OPENED BECAUSE PROCEDURAL PERSON NOTICED THE DIRT PRIOR TO OPENING. UPON FURTHER INSPECTION OF REMAINING BALLOONS, THEY DISCOVERED THAT AN ADDITIONAL 8 BALLOONS WERE SIMILARLY CONTAMINATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT IS UNKNOWN IF THE DIRT PARTICLES WERE WITHIN THE SEALED PORTION OF THE PACKAGES. THE FACILITY DOES NOT HAVE A RECEIVING BAY. THE DEVICES WERE STORED FOR APPROXIMATELY ONE MONTH PRIOR TO USE. THERE WERE NO DAMAGES NOTED TO THE SHIPPING BOXES. THERE WAS NO DAMAGE NOTED TO THE ACTUAL DEVICE PACKAGING. THE DEVICES WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17637806 ↗MalfunctionAug 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, THE FACILITY RECEIVED 10 POWERFLEX PRO BALLOONS (MULTIPLE SIZES) THAT WERE CONTAMINATED WITH DIRT PARTICLES EITHER IN BOX AND OR PACKAGING. FOR FEAR OF CONTAMINATING STERILE FIELD, TWO OF THESE BALLOONS THAT WERE GOING TO BE USED DID NOT GET OPENED BECAUSE PROCEDURAL PERSON NOTICED THE DIRT PRIOR TO OPENING. UPON FURTHER INSPECTION OF REMAINING BALLOONS, THEY DISCOVERED THAT AN ADDITIONAL 8 BALLOONS WERE SIMILARLY CONTAMINATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT IS UNKNOWN IF THE DIRT PARTICLES WERE WITHIN THE SEALED PORTION OF THE PACKAGES. THE FACILITY DOES NOT HAVE A RECEIVING BAY. THE DEVICES WERE STORED FOR APPROXIMATELY ONE MONTH PRIOR TO USE. THERE WERE NO DAMAGES NOTED TO THE SHIPPING BOXES. THERE WAS NO DAMAGE NOTED TO THE ACTUAL DEVICE PACKAGING. THE DEVICES WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17636554 ↗MalfunctionAug 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, THE FACILITY RECEIVED 10 POWERFLEX PRO BALLOONS (MULTIPLE SIZES) THAT WERE CONTAMINATED WITH DIRT PARTICLES EITHER IN BOX AND OR PACKAGING. FOR FEAR OF CONTAMINATING STERILE FIELD, TWO OF THESE BALLOONS THAT WERE GOING TO BE USED DID NOT GET OPENED BECAUSE PROCEDURAL PERSON NOTICED THE DIRT PRIOR TO OPENING. UPON FURTHER INSPECTION OF REMAINING BALLOONS, THEY DISCOVERED THAT AN ADDITIONAL 8 BALLOONS WERE SIMILARLY CONTAMINATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT IS UNKNOWN IF THE DIRT PARTICLES WERE WITHIN THE SEALED PORTION OF THE PACKAGES. THE FACILITY DOES NOT HAVE A RECEIVING BAY. THE DEVICES WERE STORED FOR APPROXIMATELY ONE MONTH PRIOR TO USE. THERE WERE NO DAMAGES NOTED TO THE SHIPPING BOXES. THERE WAS NO DAMAGE NOTED TO THE ACTUAL DEVICE PACKAGING. THE DEVICES WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17636221 ↗MalfunctionAug 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, THE FACILITY RECEIVED 10 POWERFLEX PRO BALLOONS (MULTIPLE SIZES) THAT WERE CONTAMINATED WITH DIRT PARTICLES EITHER IN BOX AND OR PACKAGING. FOR FEAR OF CONTAMINATING STERILE FIELD, TWO OF THESE BALLOONS THAT WERE GOING TO BE USED DID NOT GET OPENED BECAUSE PROCEDURAL PERSON NOTICED THE DIRT PRIOR TO OPENING. UPON FURTHER INSPECTION OF REMAINING BALLOONS, THEY DISCOVERED THAT AN ADDITIONAL 8 BALLOONS WERE SIMILARLY CONTAMINATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT IS UNKNOWN IF THE DIRT PARTICLES WERE WITHIN THE SEALED PORTION OF THE PACKAGES. THE FACILITY DOES NOT HAVE A RECEIVING BAY. THE DEVICES WERE STORED FOR APPROXIMATELY ONE MONTH PRIOR TO USE. THERE WERE NO DAMAGES NOTED TO THE SHIPPING BOXES. THERE WAS NO DAMAGE NOTED TO THE ACTUAL DEVICE PACKAGING. THE DEVICES WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17635067 ↗MalfunctionAug 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, THE FACILITY RECEIVED 10 POWERFLEX PRO BALLOONS (MULTIPLE SIZES) THAT WERE CONTAMINATED WITH DIRT PARTICLES EITHER IN BOX AND OR PACKAGING. FOR FEAR OF CONTAMINATING STERILE FIELD, TWO OF THESE BALLOONS THAT WERE GOING TO BE USED DID NOT GET OPENED BECAUSE PROCEDURAL PERSON NOTICED THE DIRT PRIOR TO OPENING. UPON FURTHER INSPECTION OF REMAINING BALLOONS, THEY DISCOVERED THAT AN ADDITIONAL 8 BALLOONS WERE SIMILARLY CONTAMINATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT IS UNKNOWN IF THE DIRT PARTICLES WERE WITHIN THE SEALED PORTION OF THE PACKAGES. THE FACILITY DOES NOT HAVE A RECEIVING BAY. THE DEVICES WERE STORED FOR APPROXIMATELY ONE MONTH PRIOR TO USE. THERE WERE NO DAMAGES NOTED TO THE SHIPPING BOXES. THERE WAS NO DAMAGE NOTED TO THE ACTUAL DEVICE PACKAGING. THE DEVICES WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17634671 ↗MalfunctionAug 8, 2023Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, A 7MM X 8CM 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED SUCCESSFULLY AND WAS REMOVED TO BE USED LATER IN THE PROCEDURE. HOWEVER, UPON FLUSHING THE BALLOON CATHETER PRIOR TO RE-USING IT, THE CATHETER SHAFT BURST. THE PROCEDURE WAS ENDED AND THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS OCCURRED DURING A PROCEDURE IN WHICH A LOWER LEG ARTERIOGRAM WAS PERFORMED. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THERE WERE NO DIFFICULTIES REMOVING THE STERILE PACKAGING COMPONENTS. THE INITIAL INFLATION OF THE BALLOON WAS BELOW THE RATED BURST PRESSURE (RBP). AFTER INITIAL USE OF THE DEVICE, THE DEVICE WAS COILED AND LAID FLAT ON THE SCRUB TABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17483347 ↗
Other Cordis Corporation products
All Cordis Corporation 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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