SABER 48006030XRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20705032068182), received between Aug 27, 2021 and Mar 16, 2026 — classified as 2 injuries, 8 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Material Frayed; Material Split, Cut or Torn

  AS REPORTED, WHEN ADVANCING A 6MM X 30MM SABER .018 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER OVER AN UNKNOWN GUIDEWIRE, THE PHYSICIAN NOTICED A TEAR HALFWAY DOWN ON THE CATHETER SHAFT. THE DEVICE WAS REMOVED FROM THE GUIDEWIRE BEFORE BEING INSERTED INTO THE PATIENT, AND A NEW UNKNOWN BALLOON WAS OPENED TO FINISH THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT IN-STENT RESTENOSIS WITH THE LEG. THE DEVICE WAS PROPERLY STORED AND OPENED IN THE STERILE FIELD AND WAS PREPPED PRIOR TO BEING ADVANCED OVER THE UNKNOWN GUIDEWIRE. THE USER WAS TRAINED TO THE DEVICE. 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 24607944 ↗
• MalfunctionJul 29, 2025Leak/Splash; Leak/Splash

  AS REPORTED, THERE WAS AN AIR LEAKAGE DUE TO A BURST CONDITION DURING THE USE OF A 6MM X 30CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. AN UNKNOWN BALLOON WAS USED AS A REPLACEMENT DEVICE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS USED INSIDE THE PATIENT, TARGETING THE SUPERFICIAL FEMORAL ARTERY (SFA), WHICH HAD MODERATE VESSEL CHARACTERISTICS. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS, AND NO OBSERVABLE DAMAGE WAS NOTED ON THE DEVICE. THERE WAS NO DIFFICULTY CONNECTING THE DEVICE TO THE LUER HUB. ADDITIONAL DETAILS WERE REQUESTED BUT WERE UNKNOWN. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED A RUPTURE ON THE BALLOON OF THE SABER PTA BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642602 ↗
• InjuryDec 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 6MM 30CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON GOT CAUGHT IN A CALCIFIED TIBIAL AND DETACHED FROM THE CATHETER AND REMAINED IN THE BODY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018759 ↗
• MalfunctionApr 12, 2024Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  AS REPORTED, DURING A CASE WHILE BALLOONING AN SFA DURING THEIR SECOND INFLATION THE 6MM 30CM SABER BALLOON WOULD NOT DEFLATE. THE PHYSICIAN FIRST TRIED WITH A SMALLER 10CC SYRINGE THEN WENT TO A 30CC SYRINGE AND WAS UNSUCCESSFUL. THE LAB THAN TRIED USING A LARGER 60CC SYRINGE TO DEFLATE AND A NEW INFLATOR DEVICE AND WERE STILL UNSUCCESSFUL. FINALLY, THE PHYSICIAN SLOWLY PULLED THE BALLOON BACK TO ABUT THE BALLOON AGAINST THE 6FR 45CM NON-CORDIS SHEATH TO RUPTURE THE BALLOON AND THEN REMOVE THE DEVICE. A FOLLOW UP ANGIOGRAM WAS TAKEN, AND NO DISSECTION OR TRAUMA WAS CAUSED TO THE PATIENT. THE DEVICE WILL BE REMOVED FROM THE PATIENT. THE DEVICE WAS STORED AS LABELED WITH THE CORRECT ROOM TEMPERATURE ON A CORDIS CONSIGNED CART. 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 DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE INTENDED LESION WAS IN THE DISEASED SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS NOTED TO HAVE A LITTLE TORTUOSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19100378 ↗
• MalfunctionMay 23, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 6MMX30CM SABER BURST AT 14ATM. THE DEVICE WAS REPLACED WITH A 6 X 25 018 SABER AFTER WITH NO ISSUES. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983050 ↗
• MalfunctionMay 31, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED, DURING THE INFLATION OF A 6MM X 30CM 150M SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AT 8 ¿ 10 ATMOSPHERES (ATM), THERE WAS A SMALL FOCAL AREA OF THE BALLOON LOCATED APPROXIMATELY 100MM FROM THE DISTAL END OF THE BALLOON THAT WOULD NOT FULLY INFLATE AND APPEARED CRIMPED UNDER FLUOROSCOPY. THERE WAS ALSO DIFFICULTY REMOVING THE BALLOON CATHETER FROM THE PATIENT WHICH REQUIRED THE USE OF A WET GAUZE, ALONG WITH KELLY CLAMPS AND FORCE TO REMOVE THE BALLOON CATHETER; HOWEVER, THE DEVICE WAS ABLE TO BE REMOVED IN ONE PIECE. AFTER REMOVAL OF THE BALLOON CATHETER, THE CRIMPED AREA OF THE BALLOON APPEARED AS IF NO INFLATION WAS MADE. AS A RESULT, A 6MM X 100MM 150CM SABER PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT WAS REPORTED THAT THE BALLOON DID MAINTAIN PRESSURE DURING ITS INFLATION AND IT WAS CONFIRMED THERE WAS NO LEAKAGE COMING FROM THE BALLOON CATHETER DURING THE ATTEMPTED INFLATION. THIS WAS DURING A PROCEDURE TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD MODERATE CALCIFICATION AND A 60% STENOSIS. THE TARGET VESSEL SHOWED NO SIGNS OF TORTUOSITY, AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14552248 ↗
• MalfunctionMay 21, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE THREE SABER 6MM 30CM BALLOONS BUSTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WHEN BEING INFLATED TO RECOMMENDED INFLATION PARAMETERS. ALL THREE DEVICES WERE REMOVED INTACT IN ONE PIECE FROM THE PATIENT. THE CASE WAS COMPLETED WITH THE USE OF A FOURTH SABER 6MMX30CM 150. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCTS WERE STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS DIFFICULTY NOTED REMOVING THE PRODUCTS FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVERS, STYLETS, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING ANY OF THE DEVICES INTO THE PATIENT. ALL THREE DEVICES WERE PREPPED PER THE IFU AND WERE ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS IN THE SUPERFICIAL FEMORAL ARTERY. THE LESION HAD MODERATE CALCIFICATION WITH LITTLE VESSEL TORTUOSITY. IT WAS A CHRONIC TOTAL OCCLUSION (CTO) TO BE TREATED. THE BALLOONS DID NOT RUPTURE WHILE IN A STENT. THE NON-CORDIS INFLATION DEVICE WAS FILLED WITH 50/50 SALINE/CONTRAST RATIO. THE INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES DURING THE CASE. THERE WAS NO RESISTANCE/FRICTION WHILE INSER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465601 ↗
• MalfunctionMay 21, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE THREE SABER 6MM 30CM BALLOONS BUSTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WHEN BEING INFLATED TO RECOMMENDED INFLATION PARAMETERS. ALL THREE DEVICES WERE REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE CASE WAS COMPLETED WITH THE USE OF A FOURTH SABER 6MMX30CM 150. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCTS WERE STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS DIFFICULTY NOTED REMOVING THE PRODUCTS FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVERS, STYLETS, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING ANY OF THE DEVICES INTO THE PATIENT. ALL THREE DEVICES WERE PREPPED PER THE IFU AND WERE ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS IN THE SUPERFICIAL FEMORAL ARTERY. THE LESION HAD MODERATE CALCIFICATION WITH LITTLE VESSEL TORTUOSITY. IT WAS A CHRONIC TOTAL OCCLUSION (CTO) TO BE TREATED. THE BALLOONS DID NOT RUPTURE WHILE IN A STENT. THE NON-CORDIS INFLATION DEVICE WAS FILLED WITH 50/50 SALINE/CONTRAST RATIO. THE INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES DURING THE CASE. THERE WAS NO RESISTANCE/FRICTION WHILE INS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465551 ↗
• MalfunctionApr 6, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 30CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 6 ATMOSPHERES (ATM) DURING AN INFLATION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AS A RESULT, A 6MM X 30MM CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY ISSUES AND THERE WAS NO REPORTED INJURY TO THE PATIENT. THE SABER PTA BALLOON CATHETER WAS BEING USED POST ATHERECTOMY VIA A 1.7MM NON-CORDIS ATHERECTOMY DEVICE AND THERE WERE NO ISSUES EXPERIENCED USING THE ATHERECTOMY DEVICE. THE SFA LESION HAD A 76% STENOSIS AND MODERATE CALCIFICATION VISUALIZED BY INTRAVASCULAR ULTRASOUND (IVUS) VIA AN .014 NON-CORDIS IVUS CATHETER, WHICH ALSO DID NOT EXPERIENCE ANY DIFFICULTY DURING ITS USE. THERE WAS NO VESSEL TORTUOSITY OR PRESENCE OF A CHRONIC TOTAL OCCLUSION (CTO) AT THE TARGET LESION. 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. ADDITIONALLY, IT WAS REPORTED THAT STAFF HAD BEEN TRAINED PRIOR TO THIS PROCEDURE. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14023400 ↗
• InjuryAug 27, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, A 6MM X 30CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED IN ITS NOMINAL PRESSURE FROM DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) TO POPLITEAL ARTERY WHEN IT RUPTURED AT 10 ATMS SEPARATING IT COMPLETELY IN HALF. THE PROXIMAL PART OF THE SABER WAS REMOVED; HOWEVER, THE DISTAL 17CM WAS NOT ABLE TO BE RETRIEVED. PHYSICIAN TRIED NUMEROUS ATTEMPTS, STRATEGIES, AND DEVICES TO REMOVE THE REMAINING BALLOON. THE PHYSICIAN THEN PERFORMED STENTING (UNKNOWN) FROM COMMON FEMORAL ARTERY (CFA) TO POPLITEAL ARTERY, FOR ASSURANCE OF RESTORED FLOW AND PATENCY. MODERATE CALCIFICATION WAS DEMONSTRATED AT THE BURST SITE. THE DEVICE WAS STORED AS PER LABELING AND OPENED IN A STERILE FIELD. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE PREPPED NORMALLY. VISIPAQUE CONTRAST MEDIA WAS USED. 70% SALINE AND 30% CONTRAST WAS USED. A NON CORDIS INFLATION DEVICE WAS USED AND USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS MODERATE CALCIFICATION THROUGHOUT THE SFA AND POP. THERE WAS LITTLE VESSEL T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380400 ↗

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