SABER 48003004SRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 20705032068069), received between Mar 27, 2017 and Dec 24, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (15 reports).

1 other recall cover devices cleared under the same FDA submission (K133843); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3MM 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED BEFORE NOMINAL EXPANSION, AND PRODUCT PERFORMANCE COULD NOT BE ACHIEVED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS BEING USED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888477 ↗
• MalfunctionJul 3, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3MM 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURE WAS CONFIRMED. THE DEVICE WAS REMOVED, AND A NEW 3MM 4CM SABER WAS USED. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS TREATED WITH AN IPSILATERAL ANTEGRADE APPROACH. THE UNKNOWN GUIDEWIRE WAS ADVANCED UNDER ULTRASOUND GUIDANCE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398256 ↗
• MalfunctionDec 6, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 3MM X 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST DURING THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO VISIBLE SIGNS OF DAMAGE TO THE DEVICE OR DEVICE PACKAGING. THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE PHYSICIAN ACHIEVED CERTIFICATION ON THE USE OF THE SABER DEVICE PRIOR TO THE PROCEDURE. THE TARGET VESSEL WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET SITE VESSEL CHARACTERISTICS INCLUDED 80% STENOSIS, WITH NO CALCIFICATION AND NO TORTUOSITY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865861 ↗
• MalfunctionMar 22, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3MM4CM SABER PTA WAS USED. HOWEVER, IT RUPTURED AT 5 ATM. 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 SHUNT CASE. THE DEVICE WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960885 ↗
• MalfunctionDec 8, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 3MM X 4CM X 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER RUPTURED AFTER BEING INFLATED WITHIN ITS NOMINAL PRESSURE. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER UNKNOWN SABER PTA DILATATION CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WERE NO PROBLEMS, EVEN THOUGH THE REPLACEMENT DEVICE WAS INFLATED SEVERAL TIMES. THE LESION WAS LOCATED ON THE SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD A CHRONIC TOTAL OCCLUSION (CTO). AN IPSILATERAL ANTEGRADE APPROACH WAS MADE. AN UNKNOWN GUIDEWIRE CROSSED THE LESION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939255 ↗
• MalfunctionJun 10, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE SABER 3MM 4CM 90 WAS BEING INFLATED AFTER THE UNKNOWN GUIDEWIRE CROSSED THE LESION; HOWEVER, IT RUPTURED WITHIN ITS NOMINAL PRESSURE. IT WAS REPLACED WITH A NEW SABER BALLOON (SAME SIZE), AFTER THAT AS SMART STENT WAS IMPLANTED AND THE CASE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY. AN ANTEGRADE IPSILATERAL APPROACH WAS MADE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14659085 ↗
• MalfunctionApr 15, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3MMX4CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS INSERTED AND INFLATED AS A PRE-DILATION HOWEVER, IT RUPTURED AT 8 ATMOSPHERES (ATM). THEREFORE, THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH A NON-CORDIS BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE DEVICE PREPPED NORMALLY BY MAINTAIN NEGATIVE PRESSURE. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD CHRONIC TOTAL OCCLUSION (CTO), 100% STENOSIS AND HAS NONE VESSEL TORTUOSITY. A NON-CORDIS GUIDEWIRE WAS CROSSED THE LESION. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE INDEFLATOR USED WAS THE EVEREST, MEDTRONIC. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9964365 ↗
• MalfunctionMar 30, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 3MM X 4CM 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED ON ITS NOMINAL PRESSURE AFTER IT WAS INFLATED AT THE LESION. THEREFORE, IT WAS REPLACED WITH SAME SIZE NEW SABER RX AND A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED. THE PROCEDURE WAS THEN CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED, PREP AND HANDLED AS PER INSTRUCTION FOR USE (IFU). THE DEVICE WAS PREP NORMALLY MAINTAINING A NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND FROM THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY STERILE PACKAGING COMPONENTS. THE CONTRAST USED WAS IN 50:50 RATIO WITH SALINE. THE INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND THROUGH THE GUIDE CATHETER. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE LESION WAS AT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH A CHRONIC TOTAL OCCLUSION (CTO). THE LESION WAS SEVERELY CALCIFIED WITH 100% STENOSIS NOTED. THE VESSEL HAS NO TORTUOSITY. A NON-CORDIS GUIDEWIRE WAS USED IN CONJUNCTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897649 ↗
• MalfunctionDec 23, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN UNKNOWN GUIDE WIRE CROSSED THE LESION; THEN A 3 MM X 4 CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER WAS INSERTED AS A PRE-DILATION. HOWEVER, IT RUPTURED WITHIN ITS NOMINAL PRESSURE. THE BALLOON DID NOT INFLATE NORMALLY AS IT RUPTURED AT 5 ATMOSPHERES. IT WAS REPLACED WITH AN UNKNOWN HIGH-PRESSURE BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO INJURY TO THE PATIENT. THIS WAS AN ENDOVASCULAR THERAPY (EVT) CASE. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY WHICH HAD CHRONIC TOTAL OCCLUSION (CTO). THERE WAS SEVERE CALCIFICATION OF THE LESION. THERE WAS NO VESSEL TORTUOSITY. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT DID LOOK NORMAL WHEN IT WAS REMOVED FROM ITS PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE CONTRAST TO SAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9512127 ↗
• MalfunctionNov 19, 2019Material Rupture; Material Rupture

  AS REPORTED, THE 3MM 4CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) RUPTURED AT EIGHT ATMOSPHERES (8ATM) AFTER A GUIDEWIRE CROSSED THE LESION. THE PRODUCTS WERE THEREFORE REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT AND THE SABER WAS REPLACED WITH ANOTHER BALLOON CATHETER OF THE SAME SIZE TO CONTINUE THE PROCEDURE . THERE WAS NO REPORTED PATIENT INJURY. THIS WAS AN ENDOVASCULAR THERAPY (EVT) CASE. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA), WHICH WAS SEVERELY CALCIFIED, HAD NO VESSEL TORTUOSITY AND WAS A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS, THE PRODUCT FROM THE HOOP, OR THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY AND PER THE IFU. A NON-CORDIS INFLATION DEVICE WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9343323 ↗
• MalfunctionAug 5, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER PTA BALLOON CATHETER (3MM4CM 90) WAS DELIVERED TO THE LESION FOR INFLATION. HOWEVER, IT RUPTURED AROUND AT 10-ATMOSPHERES PRESSURE (ATM) DURING ITS INITIAL INFLATION. THERE WAS NO REPORTED PATIENT INJURY. THEREFORE, THE SABER PTA BALLOON WAS REPLACED WITH A NON-CORDIS CUTTING BALLOON AND INFLATED AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE DISTAL PORTION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE LESION HAD HEAVY STENOSIS AND SEEMED TO BE HEAVILY CALCIFIED. INITIALLY, A NON-CORDIS 6F GUIDING SHEATH WAS INSERTED TO MAKE AN IPSILATERAL APPROACH AND A NON-CORDIS GUIDEWIRE CROSSED THE LESION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THE DEVICE WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8862247 ↗
• MalfunctionJul 18, 2019Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  AS REPORTED, THE 3MMX4CM 90¿ SABER BALLOON CATHETER (BC) WAS LEAKING FROM THE WIRE CHANNEL WHERE THE BALLOON MEETS THE WIRE AND THE BALLOON WOULD NOT HOLD PRESSURE. ADDITIONAL INFORMATION FROM THE PRODUCT EVALUATION WAS RECEIVED, INDICATING THAT THE BALLOON LEAKAGE WAS CAUSED BY A RUPTURE ON THE BALLOON SURFACE. THERE WAS NO REPORTED PATIENT. THE INTENDED PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND THE POPLITEAL ARTERY. THE LESION WAS DESCRIBED AS HAVING NO SIGNIFICANT TORTUOSITY AND A RATE OF STENOSIS OF 50%. THERE WERE NO DIFFICULTIES REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS, THE PRODUCT FROM THE HOOP, OR THE PROTECTIVE BALLOON COVER. THE DEVICE PREPPED NORMALLY. THE CONTRAST MEDIA BEING USED WAS GE HEALTHCARE OMNIPAQUE 300MG I/ML, MIXED 50:50 WITH SALINE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE INFLATION DEVICE USED WAS A NON-CORDIS DEVICE. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION ENCOUNTERED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8802217 ↗
• MalfunctionMay 20, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER 3MM X 4CM 90 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS BEING INFLATED AS A PRE DILATATION, HOWEVER, IT RUPTURED AT 6 ATMOSPHERES (ATM). THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION HAD CHRONIC TOTAL OCCLUSION (CTO) IN THE SUPERFICIAL FEMORAL ARTERY. THE PROCEDURE WAS AN EVT. A GUIDEWIRE CROSSED THE LESION BEFORE THE SABER WAS INSERTED. A NON-CORDIS BC WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS DISCARDED DUE TO THE POSSIBILITY OF INFECTIOUS DISEASES. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION HAD MODERATE CALCIFICATION. THERE WAS NOT ANY VESSEL TORTUOSITY. THERE WAS NOT ANY VESSEL ANGULATION. THE DEVICE WAS BEING USED TO TREAT CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOT ANY DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NOT ANY DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NOT ANY DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NOT ANY KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE CONTRAST TO S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8624847 ↗
• MalfunctionMay 14, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 3MMX4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS DELIVERED TO THE LESION AND INFLATED AFTER A NON-CORDIS GUIDEWIRE CROSSED THE LESION, HOWEVER IT RUPTURED AT APPROXIMATELY EIGHT TO TEN ATMOSPHERES (ATM) DURING ITS INITIAL INFLATION. NO PATIENT INJURY WAS REPORTED. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH A CHRONIC TOTAL OCCLUSION (CTO) AND ONE-HUNDRED PERCENT STENOSIS. THE DEVICE WAS REPLACED WITH A NEW NON-CORDIS BC AND THE PROCEDURE WAS CONTINUED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609461 ↗
• MalfunctionApr 13, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A SABER BALLOON CATHETER RUPTURED. IT WAS UNKNOWN HOW THE PROCEDURE COMPLETED BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. AN IPSILATERAL APPROACH WAS MADE WITH AN UNKNOWN 0.018 GUIDEWIRE AND IT CROSSED THE LESION. THEN A SABER BALLOON CATHETER WAS INSERTED FOR INFLATION HOWEVER, IT RUPTURED APPROXIMATELY AT 6 ATMOSPHERE (ATM) DURING ITS INITIAL INFLATION. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS WAS UNKNOWN. THE LESION WAS HEAVILY CALCIFIED. THE RATE OF STENOSIS WAS 99 %. THE DEVICE PREP ACCORDING TO THE INSTRUCTION FOR USE (IFU) AND NORMALLY. THERE WERE NO DAMAGES NOTED TO THE DEVICE PACKAGING. THERE WERE NO FORCE USED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE FOLLOWING INFORMATION WAS UNKNOWN: CONTRAST MEDIA USED; CONTRAST TO SALINE RATIO; TYPE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6490568 ↗
• MalfunctionMar 27, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A SABER BALLOON CATHETER RUPTURED AT 4 ATMOSPHERE (ATM) DURING INITIAL INFLATION. THEREFORE THE BALLOON WAS REPLACED WITH A NEW SABER BALLOON CATHETER AND ANOTHER UNKNOWN BALLOON CATHETER WAS INFLATED TO IMPLANT AN UNKNOWN STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. AFTER AN UNKNOWN GUIDEWIRE CROSSED THE LESION, AN UNKNOWN MICRO CATHETER WAS REMOVED AND A SABER BALLOON CATHETER WAS INSERTED WHICH RUPTURED AT 4 ATM DURING ITS INITIAL INFLATION. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6437456 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133843. One submission often covers many models, so check the product and lot details in each record.

• Z-2235-2021 · Jul 19, 2021 · Terminated
  Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X