SABER 48006010XRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20705032069615), received between Jul 2, 2021 and Jun 10, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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 16, 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.

• InjuryJun 10, 2024Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE 6MM10CM SABER BALLOON RUPTURED ON A SHELF OF CALCIUM IN THAT SUPERFICIAL FEMORAL ARTERY (SFA) WHILE ATTEMPTING TO OPEN THE DISTAL SFA. THE OVER THE WIRE (OTW) SABER CATHETER SEPARATED LEAVING BALLOON ON THE UNKNOWN WIRE IN BODY. THE WIRE WAS RETRIEVED WITH A SNARE WITH REMAINING PORTION OF BALLOON ATTACHED. THE BALLOON WAS FULLY REMOVED, AND THE CASE CONTINUED. 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 19498169 ↗
• MalfunctionAug 3, 2023Deflation Problem; Deflation Problem

  AS REPORTED, THE BALLOON OF A 6MM X 10CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD NOT MAINTAIN PRESSURE DURING AN ATTEMPTED INFLATION AND WAS UNABLE TO BE DEFLATED NORMALLY. AFTER REMOVAL OF THE DEVICE, A CRACK WAS OBSERVED ON THE HUB. A 6MM X 100MM NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT AND THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED WITH A STOPCOCK AND MAINTAINED NEGATIVE PRESSURE WHILE BEING POSITIONED IN THE BODY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17449490 ↗
• MalfunctionJun 2, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 10CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 6 ATMOSPHERES (ATM). THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING AN ANGIOPLASTY PROCEDURE TO TREAT A 70% STENOSED LESION WHICH WAS CALCIFIED. THERE WAS NO TORTUOSITY AT THE LESION AND THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED WITH A 60/40 CONTRAST AND SALINE MIXTURE AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE SABER PTA BALLOON CATHETER WAS DELIVERED OVER A NON-CORDIS GUIDEWIRE AND WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT, AS WELL AS REMAINING IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049390 ↗
• MalfunctionDec 22, 2022Component Missing; Component Missing

  AS REPORTED, A 6MM 10CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER DID NOT HAVE ANY RADIOPAQUE MARKERS INDICATING THE LOCATION OF THE BALLOON. THE MARKERS NOTED TO BE MISSING ONCE IN THE PATIENT. A NEW 6X100 SABER BALLOON WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO INCREASED LENGTH OF STAY ASSOCIATED WITH THIS EVENT. THE BALLOON WAS STORED IN A TEMP/HUMIDITY CONTROLLED ENVIRONMENT, IN THE PACKAGING/BOX, IN PROCEDURE ROOM. THE BALLOON WAS INSPECTED FOR DEFECTS PRIOR, BUT NOT FOR THE PRESENCE OF MARKERS. THE BALLOON WAS PREPPED IN THE USUAL FASHION PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON THROUGH THE SHEATH, OVER THE WIRE, OR INTO THE PATIENT. A 5F RAIN SHEATH WAS USED IN THE ANTERIOR TIBIAL ARTERY. THE LESION TO TREAT WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD MODERATE CALCIFICATION. THE PERCENTAGE OF STENOSIS WAS 100%. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (CTO). AN UNKNOWN 0.14¿ ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040410 ↗
• MalfunctionNov 9, 2022Partial Blockage; Partial Blockage

  AS REPORTED, A 6MM X 10CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS UNABLE TO ADVANCE OVER A NON-CORDIS .018 GUIDEWIRE. AS A RESULT, A NEW 6MM X 100MM CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 75% STENOSED CHRONIC TOTALLY OCCLUDED (CTO) LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS CALCIFIED BUT DID NOT SHOW SIGNS OF TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. THE DEVICE WAS NEVER PUT INTO AN ACUTE BEND, AND IT DID NOT KINK DURING ITS USE. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. ADDITIONALLY, THERE WAS NO DAMAGE TO THE NON-CORDIS .018 GUIDEWIRE, AND THE SAME GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WILL BE RETUNED FOR EVA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15764145 ↗
• MalfunctionJul 7, 2022Partial Blockage; Partial Blockage

  AS REPORTED, DURING PREPARATION OF A 6MM X 10CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE DEVICE WAS UNABLE TO BE FLUSHED THROUGH THE FLUSHING PORT. AN ATTEMPT WAS MADE TO BACK-LOAD A NON-CORDIS .014 GUIDEWIRE INTO THE 6MM X 10CM 150CM SABER PTA BALLOON CATHETER; HOWEVER, THE GUIDEWIRE WOULD NOT ADVANCE FURTHER THAN 6 INCHES. AS A RESULT, THE 6MM X 10CM 150CM SABER PTA BALLOON CATHETER WAS NOT USED IN THE PATIENT, AND A 6MM X 100MM NON-CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THE BALLOON CATHETER DID NOT KINK DURING PREPARATION OF THE DEVICE. THE GUIDEWIRE LUMEN WAS NOT BLOCKED BY POSSIBLY INJECTABLE MATERIAL, AND THERE WAS NO OBSERVED DAMAGE TO THE GUIDEWIRE LUMEN; HOWEVER, THE CATHETER PORTION JUST PROXIMAL TO THE BALLOON FELT FIRM. THE NON-CORDIS .014 GUIDEWIRE WAS USED DURING THE PROCEDURE AND REMAINED IN USE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946620 ↗
• MalfunctionMar 4, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 10CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AN INFLATION TO 6 ATMOSPHERES (ATM). THE SABER PTA BALLOON CATHETER WAS REMOVED, AND A 6MM X 10CM 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INSERTED AND INFLATED TO 10 ATM WHEN THE BALLOON OF THE POWERFLEX PRO PTA BALLOON CATHETER RUPTURED AS WELL. THERE WAS NO REPORTED INJURY TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF AN UNKNOWN STENT. THIS WAS DURING A PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO TARGET VESSEL TORTUOSITY OR PRESENCE OF A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICES WERE PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STERILE PACKAGING COMPONENTS FOR BOTH DEVICES, AND BOTH DEVICES WERE ABLE TO MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. A 50/50 CONTRAST AND SALINE MIXTURE WAS USED TO PREPARE THE BALLOONS. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED WHILE INSERTING THE DEVICES INTO THE PATIENT. THERE WAS NO DIFFICULTY EXPERIENCED WHILE ADVANCING THE DEVICES TOWARDS THE LESIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13673359 ↗
• MalfunctionJul 2, 2021Burst Container or Vessel; Burst Container or Vessel

  A 6MM X 10CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST AT 10 ATMOSPHERES (ATM) INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS DISCARDED. THE LESION WAS CALCIFIED WITH NO VESSEL TORTUOSITY. IT WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO DIFFICULTY REMOVING THE COMPLAINT BALLOON FROM THE FORMING TUBE. 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 50/50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THE MAXIMUM INFLATION PRESSURE WAS 10ATM. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED AND WAS EASILY REMOVED. PATIENT DEMOGRAPHICS INCLUDING MEDICAL HISTORY AND THE REASON FOR THE PROCEDURE WERE REQUESTED BUT WERE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12107898 ↗

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