SABER 48003030XRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 20705032069134), received between Apr 19, 2021 and Feb 13, 2026 — classified as 1 injury, 14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Burst Container or Vessel

  AS REPORTED, AFTER CROSSING WITH A .018 WIRE, PRE-DILATION WAS PERFORMED WITH A 3MM 30CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. DURING BALLOON INFLATION, IT RUPTURED WHEN PRESSURE REACHED 9 ATM; THE RATED BURST PRESSURE FOR THIS MODEL IS 14 ATM. IT WAS REPLACED WITH THE SAME MODEL SABER BALLOON TO COMPLETE THE PROCEDURE, AND NO PATIENT INJURY OCCURRED. THE PATIENT PRESENTED WITH LEFT LOWER LIMB ARTERIOSCLEROSIS OBLITERANS WITH AN ESTIMATED ~30 CM LONG-SEGMENT SUPERFICIAL FEMORAL ARTERY OCCLUSION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337994 ↗
• MalfunctionJul 3, 2025Leak/Splash; Leak/Splash

  AS REPORTED, DURING LESION DILATION, THE 3MM 30CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS FOUND TO BE LEAKING AND ALL THE CONTRAST AGENT HAD ALREADY ESCAPED. THE PROCEDURE WAS COMPLETED BY SWITCHING TO A NEW BALLOON, SPECIFICALLY A SABER DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO DIFFICULTY WAS ENCOUNTERED WHEN REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR ANY STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGE WERE NOTED PRIOR TO INSERTION. THE DEVICE WAS PREPPED PER THE IFU AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE INTENDED PROCEDURE WAS TREATMENT OF A LESION IN THE LOWER EXTREMITY ARTERY WITH ATHEROSCLEROSIS. THE LESION WAS NOT CALCIFIED, THE VESSEL HAD NO TORTUOSITY, AND THE PERCENTAGE OF STENOSIS WAS 75%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). NO RESISTANCE OR FRICTION OCCURRED WHEN INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER, AND NO DIFFICULTY WAS ENCOUNTERED ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NOT IN AN ACUTE BEND AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22397114 ↗
• MalfunctionJun 27, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN 8MM X 4CM SABERX BALLOON CATHETER RUPTURED AT 5 ATMOSPHERES (ATM) DURING ITS INITIAL INFLATION. AN 8MM X 4CM NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN ABDOMINAL AORTIC ANEURISM (AAA) STENT GRAFT PROCEDURE. THE SABERX BALLOON CATHETER WAS INFLATED AT THE LEFT RENAL ARTERY. A 6F NON-CORDIS SHEATH WAS USED DURING THIS PROCEDURE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345403 ↗
• MalfunctionJun 27, 2025Leak/Splash; Leak/Splash

  AS REPORTED, DURING USE OF A 3MM X 30CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE BALLOON WOULD NOT STAY INFLATED AND WOULD NOT HOLD PRESSURE. A NEW 3MM X 30CM SABER PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING ANGIOPLASTY OF THE POSTERIOR TIBIAL (PT) ARTERY. THERE WAS NO EVIDENCE THAT THE BALLOON WAS CAUGHT UP ON ANY CALCIUM OR PLAQUE. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION IS NOT AVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344972 ↗
• MalfunctionSep 17, 2024Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 3MM X 30CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD NOT BE FILLED AND WAS LEAKING CONTRAST FROM THE BALLOON MATERIAL. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU), AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. DURING PREPARATION, THE DEVICE MAINTAINED NEGATIVE PRESSURE. THE CONTRAST TO SALINE RATIO USED WAS 50:50. THE TARGET VESSEL WAS CHARACTERIZED BY SEVERE CALCIFICATION, NO TORTUOSITY, AND 80% STENOSIS. THE BALLOON WAS ABLE TO BE PARTIALLY INFLATED AND THERE WAS NO DIFFICULTY DEFLATING THE BALLOON. THE DEVICE WAS DISCARDED DUE TO INFECTIOUS DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239018 ↗
• MalfunctionJun 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A .018 3.0MM X 30CM SABER BALLOON SEPARATED FROM THE HUB AT THE END OF THE CATHETER. THE BALLOON CATHETER BECAME STUCK ON THE UNKNOWN WIRE. THE WIRE AND BALLOON HAD TO BE PULLED OUT AS ONE TO SAFELY REMOVE FROM THE PATIENT. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. THE CASE WAS COMPLETED WITH THE USE OF NON-CORDIS PEDAL BALLOONS. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OTHER STERILE PACKAGING COMPONENTS. THERE ARE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE INTENDED LESION WAS IN THE ANTERIOR TIBIAL ARTERY. THE LESION WAS NOT CALCIFIED. THE VESSEL WAS NOTED TO HAVE LITTLE TORTUOSITY. THERE WAS 100% STENOSIS NOTED AT THE LESION SITE. THE DEVICE WAS BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE BALLOON DEVICE THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE BAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536554 ↗
• InjuryMar 10, 2023Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED A NON-CORDIS ROTATIONAL ATHERECTOMY DEVICE WAS USED BUT COULD NOT BE ADVANCED IN THE STENT PORTION OF THE LESION. A LONG 3.0 BALLOON WAS REQUESTED BY THE PHYSICIAN, AND A 3MM X 30CM 150 SABER 3MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER BALLOON WAS USED TO CREATE A CHANNEL. DURING INFLATION, ONE PORTION OF THE BALLOON DID NOT EXPAND WELL EVEN AT HIGH INFLATION PRESSURES. THE PORTION OF THE BALLOON THAT DID NOT EXPAND WAS IN THE OLD STENT FROM PRIOR YEARS. THE MAXIMUM INFLATION PRESSURE WAS 12 ATM AND THE BALLOON MAINTAINED PRESSURE DURING INFLATION UNTIL IT POPPED. AS THE PHYSICIAN WAS WALKING OUT THE BALLOON, IT WAS NOTICED THAT THE DISTAL MARKERS WERE NOT MOVING BUT THE SHAFT OF THE BALLOON WAS ABLE TO BE WALKED OUT OVER THE WIRE. THE BALLOON IN FULL WAS STILL IN THE ARTERY. AS PER THE PHYSICIAN, ¿THE BALLOON GOT STUCK ON A FRACTURED STENT¿ AND DETACHED. THE PHYSICIAN USED FORCE TO ATTEMPT REMOVAL AS THE BALLOON WAS STUCK ON A FRACTURED STENT AND CALCIUM. AN ENSNARE WAS ADVANCED OVER AN UNKNOWN 0.018 ROTATIONAL ATHERECTOMY WIRE AND PULLED OUT THE BALLOON WITH NO PROBLEMS. AFTER THAT, THE INTERVENTION WENT SMOOTH, AND STENTING AND BALLOONING OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520942 ↗
• MalfunctionFeb 17, 2023Partial Blockage; Partial Blockage

  AS REPORTED, SOON AS THE SABER 3MM 30CM BALLOON WAS REMOVED FROM THE PACKAGING, THERE WAS A DEFECT NOTED BECAUSE THERE WAS NO PROGRESSION OF SALINE SOLUTION IN THE ATTEMPT TO WASH THE CATHETER AND ALSO NO PROGRESSION OF THE GUIDE WIRE. IT WAS INTERNALLY BLOCKED. THE CASE WAS COMPLETED WITH THE USE OF ANOTHER UNKNOWN WIRE AND BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396714 ↗
• MalfunctionJun 6, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THERE WAS A LEAKAGE COMING FROM THE BALLOON OF A 3MM X 30CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WHICH WAS UNABLE TO BE FULLY INFLATED DURING AN ATTEMPTED INFLATION TO 15 ATMOSPHERES (ATM). A SECOND 3MM X 30CM 150CM SABER PTA BALLOON CATHETER WAS USED FOR THE PROCEDURE AND EXPERIENCED THE SAME ISSUE OF LEAKAGE, AND AN INABILITY TO BE FULLY INFLATED. AS A RESULT, A THIRD 3MM X 30CM SABER PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A LESION BELOW THE KNEE WHICH HAD A 78% STENOSIS. THE LESION WAS NOT CALCIFIED, TORTUOUS, AND WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THE INITIAL 3MM X 30CM 150CM SABER PTA BALLOON CATHETER WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. A 1:1 CONTRAST TO SALINE RATIO WAS USED TO PREP THE BALLOON. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602019 ↗
• MalfunctionJun 2, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THERE WAS A LEAKAGE COMING FROM THE BALLOON OF A 3MM X 30CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WHICH WAS UNABLE TO BE FULLY INFLATED DURING AN ATTEMPTED INFLATION TO 15 ATMOSPHERES (ATM). A SECOND 3MM X 30CM 150CM SABER PTA BALLOON CATHETER WAS USED FOR THE PROCEDURE AND EXPERIENCED THE SAME ISSUE OF LEAKAGE, AND AN INABILITY TO BE FULLY INFLATED. AS A RESULT, A THIRD 3MM X 30CM SABER PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A LESION BELOW THE KNEE WHICH HAD A 78% STENOSIS. THE LESION WAS NOT CALCIFIED, TORTUOUS, AND WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THE INITIAL 3MM X 30CM 150CM SABER PTA BALLOON CATHETER WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. A 1:1 CONTRAST TO SALINE RATIO WAS USED TO PREP THE BALLOON. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14576398 ↗
• MalfunctionMar 11, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 3MM X 30CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING A TEST OUTSIDE OF THE PATIENT. AS A RESULT, AN UNKNOWN BALLOON CATHETER WAS USED IN PLACE OF THE 3MM X 30CM 150CM SABER PTA BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT AS THE SABER PTA BALLOON CATHETER WAS NEVER INSERTED INTO THE PATIENT. THE BALLOON WAS NOT BEING TESTED DUE TO AN OBSERVED MALFUNCTION. INFORMATION REGARDING PATIENT AGE, WEIGHT, GENDER, EVENT DATE, INTENDED PROCEDURE, TARGET LESION, THE PREPARATION OF THE DEVICE, TYPE OF CONTRAST USED, CONTRAST TO SALINE RATIO, TYPE OF INFLATION DEVICE USED, AND ATMOSPHERES (ATM) REACHED AT THE POINT OF BURST WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13739110 ↗
• MalfunctionJul 30, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 3MM X 30CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST WHEN IT DIDN'T HIT THE WORKING PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS SEVERELY CALCIFIED. THERE WAS SEVERE VESSEL TORTUOSITY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR 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 DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). A NON-CORDIS INFLATION DEVICE WAS USED. THE SAME INDEFLATOR WAS NOT USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO 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 BALLOON INFLATED NORMALLY. THE BALLOON CATHETER DID NOT KINK WHILE BEING U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12251497 ↗
• MalfunctionJun 14, 2021Leak/Splash; Leak/Splash

  AS REPORTED, THE BODY OF THE BALLOON OF 3MM X 30CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER LEAKED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR ANY 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 INTO THE PATIENT. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS NOT CALCIFIED AND HAD NO VESSEL TORTUOSITY. THERE WAS EIGHTY FIVE PERCENT STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE MAXIMUM INFLATION PRESSURE WAS SIXTEEN ATMOSPHERES. THE PROCEDURE WAS COMPLETED BY USING ANOTHER BALLOON. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11990639 ↗
• MalfunctionJun 3, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BODY OF THE 3MM X 30CM X 150CM SABER BALLOON CATHETER (BC) WAS RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DESTROYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11929782 ↗
• MalfunctionApr 19, 2021Material Rupture; Material Rupture

  DURING AN INTERVENTIONAL PROCEDURE THE BODY OF A 3MM X 30CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER LEAKED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY CHANGING TO ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS A 78% OCCLUDED LESION IN THE LOWER LIMB WITH SOME VESSEL TORTUOSITY. THE ACCESS SITE WAS THE SUPERFICIAL FEMORAL ARTERY. 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 1:1. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE BALLOON DID NOT INFLATE NORMALLY. THE MAXIMUM INFLATION PRESSURE WAS 15ATM. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11684821 ↗

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