SABER 48006015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20705032069622), received between Dec 12, 2019 and Feb 24, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Leak/Splash

  AS REPORTED, THE PHYSICIAN WAS USING A 6MM 15CM .018 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. AFTER HIS 4TH INFLATION IN THE PATIENT'S RIGHT LEG (CFA/SFA) THE BALLOON HAD DEVELOPED A SMALL LEAK. THIS WAS DISCOVERED WHEN THE BALLOON WAS DEFLATED AND SLIGHTLY BLOODY SALINE CAME BACK INTO THE INFLATION DEVICE THAT WE BEING USED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. AFTER BLOOD WAS OBSERVED IN THE INFLATION DEVICE, THE BALLOON WAS REMOVED AND THE PROCEDURE CONCLUDED SUCCESSFULLY, WITH THE PATIENT REMAINING STABLE. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO DIFFICULTIES NOTED DURING REMOVAL FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET, OR OTHER STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE OBSERVED PRIOR TO INSERTION, AND THE DEVICE WAS PREPPED CORRECTLY, MAINTAINING NEGATIVE PRESSURE. THE INTENDED PROCEDURE TARGETED THE COMMON FEMORAL ARTERY (CFA), SUPERFICIAL FEMORAL ARTERY (SFA), AND POPLITEAL ARTERY (POP). NO RESISTANCE OR FRICTION WAS NOTED DURING INSERTION THROUGH THE ROTATING HEMOSTATIC VALVE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431573 ↗
• MalfunctionAug 29, 2025Burst Container or Vessel; Burst Container or Vessel

  A REPORTED, THERE WAS AN ISSUE WITH THE HYPOTUBE ON A 2MM X 150MM SABER .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AND THE DEVICE WOULD NOT TRACK UP A NON-CORDIS GUIDEWIRE AND INTO THE PATIENT. RESISTANCE WAS EXPERIENCED INSIDE THE BALLOON AREA OF THE SABER .014 BALLOON CATHETER, PREVENTING IT FROM GOING ON THE WIRE NORMALLY WHEN INSERTING FROM THE DISTAL TIP. ADDITIONALLY, THERE WAS SOME DIFFICULTY FLUSHING THE GUIDEWIRE LUMEN, BUT IT WAS NOT BLOCKED WITH INJECTABLE MATERIAL. A NEW CORDIS BALLOON CATHETER WAS OPENED AND USED. THE SAME GUIDEWIRE WAS SUCCESSFULLY USED WITH THE REPLACEMENT BALLOON CATHETER WITHOUT ISSUE. LATER IN THE PROCEDURE, A 6MM X 15CM SABER PTA BALLOON CATHETER WAS OPENED; HOWEVER, THE BALLOON BURST ON CALCIUM. A NEW CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT AND THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT CHRONIC TOTAL OCCLUSION (CTO) WITH CALCIUM THROUGHOUT, THOUGH NOT SEVERE. THE SABER .014 DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE SABER .018 DEVICE WAS ALSO STORED AND PREPPED PER THE IFU, WITH NO DIFFICULTY REMOVING STERILE PACKAGING COMPONENTS. THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22921087 ↗
• MalfunctionApr 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE GUIDEWIRE DELIVERY LUMEN AT THE TIP END OF THE BALLOON ON A 6MM X 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATION CATHETER IS A FRACTION SHORTER. THERE WERE NO REPORTS OF PATIENT INJURY. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. THE DEVICE WAS RETURNED FOR EVALUATION. THE UNIT WAS THOROUGHLY INSPECTED OBSERVING A SEPARATION CONDITION AT THE DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755156 ↗
• MalfunctionJul 23, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 6MM 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED AT/BELOW RBP DURING THE LOWER LIMB ARTERY SURGERY. THEREFORE, THE SURGERY COULD NOT BE PERFORMED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE CASE WAS COMPLETED WITH A NEW SABER BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED PROPERLY PER 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 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. THE INTENDED LESION WAS AT THE OPENING OF THE SUPERFICIAL FEMORAL ARTERY WHICH HAD A TOTAL OCCLUSION. THE LESION HAD SEVERE CALCIFICATION. THE CONTRAST/SALINE RATIO WAS 50/50. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804882 ↗
• MalfunctionJun 14, 2024Deflation Problem; Deflation Problem

  AS REPORTED, AFTER DILATION OF A 6MM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, IT WAS DIFFICULT TO REVERT THE BALLOON BACK TO ITS ORIGINAL STATE. AN ATTEMPT TO REINFLATE THE BALLOON WAS MADE, BUT THE BALLOON COULD NOT FILL COMPLETELY. THE DEVICE WAS REMOVED, AND AN UNKNOWN DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE IN WHICH A RETROGRADE PUNCTURE WAS MADE IN THE LEFT FEMORAL ARTERY. AN ANGIOGRAM WAS PERFORMED WHICH SHOWED OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). 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 19538956 ↗
• MalfunctionMar 15, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 15CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER POPPED AFTER AN INFLATION TO 11AMOSPHERES (ATM) WITHIN AN UNKNOWN CORDIS STENT WHICH WAS PLACED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AS A RESULT, A 6MM X 10CM SABER PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. POST DILATION OF THE UNKNOWN CORDIS STENT WAS PERFORMED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PERIPHERAL INTERVENTIONAL PROCEDURE TO TREAT A 100% STENOSED, CHRONIC TOTALLY OCCLUDED (CTO) LESION IN THE SFA. THE LESION DID NOT HAVE ANY CALCIFICATION OR TORTUOSITY PRESENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE BALLOON WAS PREPPED WITH A 50/50 CONTRAST AND SALINE MIXTURE. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE THOUGH THE IMPLANTED STENT. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16544614 ↗
• MalfunctionOct 7, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED, AFTER THE SUCCESSFUL INFLATION OF A 6MM X 15CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE DEVICE BECAME STUCK INSIDE OF AN UNKNOWN CATHETER SHEATH INTRODUCER (CSI) AND WAS UNBALE TO BE REMOVED. IT WAS REPORTED THAT EVERYTHING HAD TO BE REMOVED, INCLUDING THE UNKNOWN CSI, IN ORDER TO REMOVE THE SABER PTA BALLOON CATHETER FROM THE PATIENT. THE SABER BALLOON CATHETER WAS THEN CUT SO IT COULD BE REMOVED FROM THE SHEATH. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED, AND THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15565756 ↗
• MalfunctionSep 24, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING THE INFLATION OF 6MM X 15CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO ITS CORRECT PRESSURE, THE BALLOON RUPTURED. A SECOND 6MM X 15M 150CM SABER PTA BALLOON CATHETER WAS USED; HOWEVER, THE BALLOON OF THE SECOND SABER PTA BALLOON CATHETER RUPTURED DURING AN INFLATION TO ITS CORRECT PRESSURE AS WELL. A 6MM X 15CM 135CM POWERFLEX PRO PTA BALLOON CATHETER WAS THEN USED AND WAS ABLE TO CROSS THE LESION SUCCESSFULLY. THE POWERFLEX PRO PTA BALLOON CATHETER WAS REMOVED FOR AN UNDISCLOSED REASON, AND AN ATTEMPT TO RE-INSERT THE DEVICE WAS MADE. PRIOR TO RE-INSERTION OF THE DEVICE, KINKING WAS OBSERVED ON THE DEVICE, AND IT WAS DECIDED NOT TO RE-INSERT THE POWERFLEX PRO PTA BALLOON CATHETER. AS A RESULT, AN UNKNOWN BALLOON CATHETER WAS USED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WERE ALL STORED CORRECTLY AND WERE BEING HANDED BY AN EXPERIENCED USER. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15479833 ↗
• MalfunctionSep 24, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING THE INFLATION OF 6MM X 15CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO ITS ¿CORRECT PRESSURE¿, THE BALLOON RUPTURED. A SECOND 6MM X 15M 150CM SABER PTA BALLOON CATHETER WAS USED; HOWEVER, THE BALLOON OF THE SECOND SABER PTA BALLOON CATHETER RUPTURED DURING AN INFLATION TO ITS ¿CORRECT PRESSURE¿ AS WELL. A 6MM X 15CM 135CM POWERFLEX PRO PTA BALLOON CATHETER WAS THEN USED AND WAS ABLE TO CROSS THE LESION SUCCESSFULLY. THE POWERFLEX PRO PTA BALLOON CATHETER WAS REMOVED FOR AN UNDISCLOSED REASON, AND AN ATTEMPT TO RE-INSERT THE DEVICE WAS MADE. PRIOR TO RE-INSERTION OF THE DEVICE, KINKING WAS OBSERVED ON THE DEVICE, AND IT WAS DECIDED NOT TO RE-INSERT THE POWERFLEX PRO PTA BALLOON CATHETER. AS A RESULT, AN UNKNOWN BALLOON CATHETER WAS USED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WERE ALL STORED CORRECTLY AND WERE BEING HANDED BY AN EXPERIENCED USER. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15479182 ↗
• MalfunctionDec 12, 2019Material Rupture; Material Rupture

  DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA), A THE 6MM X 15CM X 150CM SABER PTA BALLOON CATHETER RUPTURED. THERE WAS NO PATIENT INJURY AND THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE DEVICE WAS OPENED IN A STERILE FIELD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9458615 ↗

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