MAXI LDRecalls & reported problems across all models

We found 17 models of MAXI LD by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2017 and Jun 9, 2025 — classified as 5 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (51 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

Most reported MAXI LD problems

MAXI LD models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MAXI LD 4171640S

  Catheter, angioplasty, peripheral, transluminal
  10 reports
• MAXI LD 4161540L

  Catheter, angioplasty, peripheral, transluminal
  8 reports
• MAXI LD 4171660S

  Catheter, angioplasty, peripheral, transluminal
  6 reports
• MAXI LD 4171440S

  Catheter, angioplasty, peripheral, transluminal
  5 reports
• MAXI LD 4171860S

  Catheter, angioplasty, peripheral, transluminal
  5 reports
• MAXI LD 4162040L

  Catheter, angioplasty, peripheral, transluminal
  4 reports
• MAXI LD 4162540L

  Catheter, angioplasty, peripheral, transluminal
  4 reports
• MAXI LD 4161440L

  Catheter, angioplasty, peripheral, transluminal
  3 reports
• MAXI LD 4171840S

  Catheter, angioplasty, peripheral, transluminal
  3 reports
• MAXI LD 4161460L

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• MAXI LD 4171460L

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• MAXI LD 4171460S

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• MAXI LD 4161640S

  Catheter, angioplasty, peripheral, transluminal
  1 report
• MAXI LD 4161840L

  Catheter, angioplasty, peripheral, transluminal
  1 report
• MAXI LD 4171440L

  Catheter, angioplasty, peripheral, transluminal
  1 report
• MAXI LD 4171660L

  Catheter, angioplasty, peripheral, transluminal
  1 report
• MAXI LD 4171840L

  Catheter, angioplasty, peripheral, transluminal
  1 report

Recent MAXI LD adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF A 14MM X 6CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS CAUGHT DURING THE PROCEDURE AND FELL OFF. THE BALLOON WAS CAUGHT DURING REMOVAL FROM A NON-CORDIS STENT AND THE SEPARATION OCCURRED WHILE TRYING TO WITHDRAW THE BALLOON CATHETER. THERE WERE ATTEMPTS TO RETRIEVE THE SEPARATED SEGMENT FROM THE PATIENT USING AN UNKNOWN DEVICE; HOWEVER, THE RETRIEVAL WAS UNSUCCESSFUL, AND THE PATIENT WAS TRANSPORTED BY AMBULANCE TO THE HOSPITAL FOR SURGERY. THE SEPARATED SEGMENT WAS SUCCESSFULLY REMOVED DURING THE SURGICAL INTERVENTION. THE TARGET VESSEL WAS THE ILIAC VEIN, WHICH WAS NEITHER CALCIFIED NOR TORTUOUS. THE SEPARATION OCCURRED IN THE ILIAC VEIN. 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 WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168095 ↗
• MalfunctionJan 19, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOONS OF A 16MM X 6CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AND A 16MM X 4CM MAXI LD PTA BALLOON CATHETER RUPTURED WHEN DEPLOYED THROUGH AN UNKNOWN STENT. THERE WERE NO REPORT INJURIES TO THE PATIENT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545426 ↗
• MalfunctionJan 19, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOONS OF A 16MM X 6CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AND A 16MM X 4CM MAXI LD PTA BALLOON CATHETER RUPTURED WHEN DEPLOYED THROUGH AN UNKNOWN STENT. THERE WERE NO REPORT INJURIES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545341 ↗
• MalfunctionJul 20, 2023Difficult to Remove; Difficult to Remove

  AS REPORTED, PHYSICIAN NOTED THE 7F 18X4 MAXI LD BALLOON "MALFUNCTIONED" DURING THE CASE. NO PATIENT INJURIES NOTED. THE PHYSICIAN WAS ABLE TO REMOVE THE BALLOON AFTER PULLING HARDER ON IT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, BOTH WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17364199 ↗
• MalfunctionMay 9, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 7F MAXI LD 14X4 BALLOON RUPTURED DURING A CASE. IT NEVER ACHIEVED PRESSURE. THIS BALLOON SIMPLY RUPTURED BEFORE ANY SIGNIFICANT PRESSURE WAS ATTAINED. NOTHING OUT OF THE ORDINARY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896743 ↗
• MalfunctionApr 28, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THREE MAXI LD BALLOONS ON ONE CASE WERE USED AND ALL THREE BURST AT NOMINAL PRESSURE. THERE WERE TWO 14X6 BALLOONS AND ONE 14X4 BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCTS WERE STORED PROPERLY PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE BALLOONS FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVERS, STYLETS, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE BALLOONS WERE PREPPED PER THE IFU. THE DEVICE PREPPED NORMALLY WITHOUT DIFFICULTY. THE INTENDED LESION WAS IN THE COMMON FEMORAL (VENOUS). THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOONS THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY NOTED WHILE ADVANCING THE BALLOONS THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE SAME INFLATION DEVICE WAS USED WITH OTHER DEVICES DURING THE PROCEDURE. ALL DEVICES WERE REMOVED INTACT FROM THE PATIENT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE NOT SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16835237 ↗
• MalfunctionApr 28, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THREE MAXI LD BALLOONS ON ONE CASE WERE USED AND ALL THREE BURST AT NOMINAL PRESSURE. THERE WERE TWO 14X6 BALLOONS AND ONE 14X4 BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCTS WERE STORED PROPERLY PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE BALLOONS FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVERS, STYLETS, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE BALLOONS WERE PREPPED PER THE IFU. THE DEVICE PREPPED NORMALLY WITHOUT DIFFICULTY. THE INTENDED LESION WAS IN THE COMMON FEMORAL (VENOUS). THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOONS THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY NOTED WHILE ADVANCING THE BALLOONS THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE SAME INFLATION DEVICE WAS USED WITH OTHER DEVICES DURING THE PROCEDURE. ALL DEVICES WERE REMOVED INTACT FROM THE PATIENT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE NOT SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16835019 ↗
• MalfunctionApr 24, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, TWO 7F 16X4 MAXI LD BALLOONS RUPTURED DURING POST DILATATION OF VENOUS STENT. THE BALLOONS WERE ONLY INFLATED TO 4 ATM BEFORE RUPTURING. UPON REMOVAL OF THE SECOND DEVICE, THE BALLOON COMPLETELY SEPARATED. THIS OCCURRED WHILE TRYING TO REMOVE THE BALLOON FROM THE SHEATH. THE SHEATH HAD TO BE REMOVED WITH BALLOON AND WIRE, SHEATH THEN HAD TO BE CUT OPEN TO REMOVE THE BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS AN IMAGE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794245 ↗
• MalfunctionApr 24, 2023Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, TWO 7F 16X4 MAXI LD BALLOONS RUPTURED DURING POST DILATATION OF VENOUS STENT. THE BALLOONS WERE ONLY INFLATED TO 4 ATM BEFORE RUPTURING. UPON REMOVAL OF THE SECOND DEVICE, THE BALLOON COMPLETELY SEPARATED. THIS OCCURRED WHILE TRYING TO REMOVE THE BALLOON FROM THE SHEATH. THE SHEATH HAD TO BE REMOVED WITH BALLOON AND WIRE, SHEATH THEN HAD TO BE CUT OPEN TO REMOVE THE BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS AN IMAGE WAS PROVIDED. THE PICTURE SHOWS THE DISTAL SECTION OF THE 2 UNITS. SAMPLE # 1, IT COULD BE NOTICED THE BALLOON DEFLATED AND BLOOD RESIDUES. SAMPLE # 2, IT COULD BE NOTICED THE BALLOON BURST AND SEPARATED. NO OTHER ANOMALIES OF THE PRODUCT CAN BE NOTICED AT THE ATTACHED PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794241 ↗
• MalfunctionApr 3, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING THE USE OF A 14X6 80CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE BALLOON IMMEDIATELY RUPTURED DURING AN ATTEMPTED INFLATION AND THE BALLOON WAS UNABLE TO BE PRESSURIZED. AS A RESULT, A NEW 14X6 80CM MAXI LD PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS BEING USED TO POST DILATE AN UNKNOWN VENOUS STENT. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. A 1:2 CONTRAST TO SALINE RATIO WAS USED TO PREP THE BALLOON. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665737 ↗
• MalfunctionMar 10, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOONS OF TWO (2) 7F 18MM X 6MM X 80CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS BURST DURING ANGIOPLASTY OF THE ILIAC VEIN. THE BALLOON BURST OCCURRED DURING INITIAL INFLATION AT 4 ATMOSPHERES (ATM). THE DEVICES DID NOT INFLATE NORMALLY; LEAKAGE WAS NOTED FROM THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS MODERATE TARGET LESION VESSEL CALCIFICATION AND MILD VESSEL TORTUOSITY. THE PERCENTAGE STENOSIS WAS NOT PROVIDED. THE DEVICE WAS NOT BEING USED FOR A CHRONIC TOTAL OCCLUSION. THE DEVICES WERE PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE PRODUCTS WERE PROPERLY STORED AND OPENED IN STERILE FIELD. THERE WERE NO VISIBLE VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE DEVICES PREPPED NORMALLY MAINTAINING NEGATIVE PRESSURE. THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. THERE WERE NO KINKS/BENDS NOTED AFTER THE DEVICES WERE REMOVED FROM PATIENT. NO UNUSUAL FORCE WAS USED AT ANY TIME DURING THE PROCEDURE. THE DEVICES WERE REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE USER IS TRAINED TO THE DEVICE. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526465 ↗
• MalfunctionMar 10, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOONS OF TWO (2) 7F 18MM X 6MM X 80CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS BURST DURING ANGIOPLASTY OF THE ILIAC VEIN. THE BALLOON BURST OCCURRED DURING INITIAL INFLATION AT 4 ATMOSPHERES (ATM). THE DEVICES DID NOT INFLATE NORMALLY; LEAKAGE WAS NOTED FROM THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS MODERATE TARGET LESION VESSEL CALCIFICATION AND MILD VESSEL TORTUOSITY. THE PERCENTAGE STENOSIS WAS NOT PROVIDED. THE DEVICE WAS NOT BEING USED FOR A CHRONIC TOTAL OCCLUSION. THE DEVICES WERE PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE PRODUCTS WERE PROPERLY STORED AND OPENED IN STERILE FIELD. THERE WERE NO VISIBLE VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE DEVICES PREPPED NORMALLY MAINTAINING NEGATIVE PRESSURE. THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. THERE WERE NO KINKS/BENDS NOTED AFTER THE DEVICES WERE REMOVED FROM PATIENT. NO UNUSUAL FORCE WAS USED AT ANY TIME DURING THE PROCEDURE. THE DEVICES WERE REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE USER IS TRAINED TO THE DEVICE. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526292 ↗
• MalfunctionMar 6, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE DOCTOR REPORTED THAT THE MAXI LD 14X4 BALLOON BURST AFTER BEING INFLATED RESPECTING THE NOMINAL PRESSURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, BOTH WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE. TWO IMAGES WERE NOTED ON THE FILE. ON THE FIRST IMAGE THE POUCH OF A MAXI LD REF 416-1440L LOT 82246340 IS NOTED. ON THE SECOND IMAGE A PLASTIC BAG WITH THE DEVICE INSIDE IS OBSERVED, HOWEVER THE UNIT CANNOT BE INSPECTED, THUS NO ANOMALIES WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486772 ↗
• MalfunctionMar 1, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AFTER AN UNKNOWN STENT WAS IMPLANTED, TWO 7F MAXI LD 14X4 80CM BALLOONS RUPTURED. THE FIRST MAXI BALLOON WAS USED, BUT IT RUPTURED AT 4 ATM. A SECOND MAXI (SAME SIZE) WAS USED, AND IT RUPTURED IN THE SAME AREA AT 4 ATM. THERE WAS NO REPORTED PATIENT INJURY. THIS OCCURRED DURING A LEFT VENOGRAM. THE DEVICE WERE DISPOSED/DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461635 ↗
• MalfunctionMar 1, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AFTER AN UNKNOWN STENT WAS IMPLANTED, TWO 7F MAXI LD 14X4 80CM BALLOONS RUPTURED. THE FIRST MAXI BALLOON WAS USED, BUT IT RUPTURED AT 4 ATM. A SECOND MAXI (SAME SIZE) WAS USED, AND IT RUPTURED IN THE SAME AREA AT 4 ATM. THERE WAS NO REPORTED PATIENT INJURY. THIS OCCURRED DURING A LEFT VENOGRAM. THE DEVICE WERE DISPOSED/DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461633 ↗

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