SABER 48008004SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20705032068908), received between Nov 16, 2016 and Jan 6, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 8MM 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS FLUSHED AS PER THE INSTRUCTIONS FOR USE (IFU). AFTER THAT, IT WAS USED AT THE LESION. HOWEVER, THERE WAS DISCOMFORT IN THE WIRE L UMEN, WHICH EVENTUALLY LED TO SNAP APART. THE SNAP PART WAS SAFELY RETRIEVED. THIS WAS A SHUNT PTA CASE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080884 ↗
• MalfunctionOct 4, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN 8MM X 4CM 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AN INITIAL INFLATION TO 6 ATMOSPHERES (ATM). A NEW 8MM X 4CM SABER PTA BALLOON CATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN INTERVENTIONAL PROCEDURE TO TREAT A SUBCLAVIAN VEIN LESION. A NON-CORDIS .018 GUIDEWIRE WAS USED FOR THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17867978 ↗
• MalfunctionDec 26, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE SABER 8MM 4CM BALLOON RUPTURED AT 8 ATM DURING THE INITIAL INFLATION. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE SABER WAS REPLACED WITH A NON-CORDIS 8MM 4CM BALLOON CATHETER AND A SMART STENT WAS IMPLANTED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS THE ILIAC ARTERY. AN IPSILATERAL APPROACH WAS MADE. AN UNKNOWN .018 GUIDEWIRE CROSSED THE LESION, AND THE SABER PTA WAS USED AS PRE DILATION. 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 PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPER PER THE IFU AND WAS PREPPED NORMALLY. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE DEVICE THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE LESION WAS NOTED TO HAVE SEVER CALCIFICATION. THE VESSEL HAD MODERATE TORTUOSITY. THE DEVICE DID NOT HAVE ANY DIFFICULTY WHILE ADVANCING TOWARDS THE LESION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048332 ↗
• MalfunctionMar 4, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN 8MM X 4CM 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED. THEREFORE, THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT¿S BODY AND REPLACED WITH A NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE SABER BALLOON WAS USED FOR A SHUNT PTA CASE. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO DAMAGES NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. 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 OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). 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 GUIDE CATHETER. THE TARGET LESION WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9786295 ↗
• MalfunctionSep 30, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN 8MM 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST IN THE PATIENT. ANOTHER PTA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS INTERVENTIONAL AND THE TARGET LESION WAS THE "VENOUS ARM". THE DEVICE WAS STORED IN THE OPERATING ROOM (OR) FOR LESS THAN ONE (1) YEAR. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR THE STYLET. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE. THE LESION HAD MODERATE CALCIFICATION AND 95% STENOSIS. THERE WAS NO VESSEL ANGULATION OR TORTUOSITY. THERE WAS NO REPORTED DIFFICULTY CROSSING THE LESION. THE CONTRAST TO SALINE RATIO WAS 40/60. IT WAS NOTED THAT THE BALLOON RUPTURED AT AN INFLATION PRESSURE OF TEN (10) ATM. THE BALLOON CATHETER WAS REMOVED EASILY AND INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9136708 ↗
• MalfunctionSep 26, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 80 MM X 4 CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST IN THE PATIENT. ANOTHER SABER PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. THE DEVICE WAS INTENDED TO BE USED IN A FISTULA ARM CASE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM ITS PACKAGING. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE CONTRAST TO SALINE RATIO WAS 40/60. A NON-CORDIS INFLATION DEVICE WAS USED, WHICH HAD PREVIOUSLY BEEN SUCCESSFULLY USED WITH OTHER DEVICES. THE FISTULA HAD LITTLE CALCIFICATION, NO TORTUOSITY AND HAD A RATE OF 90% STENOSIS. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL, NOR WAS THERE ANY DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE PLUNGER DID NOT DEPRESS INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. THE MAXIMUM INFLATION PRESSURE WAS 12ATM. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9125413 ↗
• MalfunctionMar 13, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A SABER 8MM4CM 90 BALLOON RUPTURE. THEREFORE THE BALLOON WAS REPLACED WITH A NON CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. A SABER BALLOON WAS INFLATED BUT IT RUPTURED AT 10ATM DURING INITIAL-DILATION. THE TARGET LESION WAS THE SHUNT VESSEL (PTA). THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6400759 ↗
• MalfunctionNov 16, 2016Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE TIP OF THE CATHETER OF A SABER BALLOON 8MM4CM 90 HAS COME OFF WHILE IT WAS BEING PUT ON THE WIRE. THERE WAS NO PATIENT INJURIES. THE DEVICE WAS NEVER USED IN THE PATIENT. THE DEVICE IS AVAILABLE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6105963 ↗

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